Systems for and methods of preparing a sacroiliac joint for fusion

ABSTRACT

A surgical preparation tool for preparing a sacroiliac joint for a surgical procedure comprising a trial tool assembly and a cutting tool configured to releasably and slidably couple with the trial tool assembly, wherein the trial tool assembly is configured to guide the cutting tool during distal-proximal translation such that as the cutting tool distally advances relative to an implant trial of the trial tool assembly, at least a portion of a cutting element of the cutting tool extends generally over and perpendicularly outward from a first top surface of a body of the implant trial.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims priority under 35 U.S.C. §119 to U.S.Provisional Patent Application 61/891,330, which was filed Oct. 15,2013, entitled “SYSTEMS FOR AND METHODS OF FUSING A SACROILIAC JOINT,”and is hereby incorporated by reference in its entirety into the presentapplication.

The present application also claims priority under 35 U.S.C. §119 toU.S. Provisional Patent Application 61/891,345, which was filed Oct. 15,2013, entitled “SYSTEMS FOR AND METHODS OF FUSING A SACROILIAC JOINT,”and is hereby incorporated by reference in its entirety into the presentapplication.

The present application also claims priority under 35 U.S.C. §119 toU.S. Provisional Patent Application 61/912,494, which was filed Dec. 5,2013, entitled “SYSTEMS FOR AND METHODS OF FUSING A SACROILIAC JOINT,”and is hereby incorporated by reference in its entirety into the presentapplication.

The present application also claims priority under 35 U.S.C. §119 toU.S. Provisional Patent Application 61/914,409, which was filed Dec. 11,2013, entitled “SYSTEMS FOR AND METHODS OF FUSING A SACROILIAC JOINT,”and is hereby incorporated by reference in its entirety into the presentapplication.

The present application also claims priority under 35 U.S.C. §119 toU.S. Provisional Patent Application 61/954,594, which was filed Mar. 17,2014, entitled “SYSTEMS AND METHODS FOR FUSING A SACROILIAC JOINT ANDANCHORING AN ORTHOPEDIC APPLIANCE,” and is hereby incorporated byreference in its entirety into the present application.

The present application is also a continuation-in-part (“CIP”)application of, and claims priority to, U.S. patent application Ser. No.14/447,612 (“the '612 application”), which was filed Jul. 31, 2014,entitled “SYSTEMS FOR AND METHODS OF FUSING A SACROILIAC JOINT.” The'612 application claims priority under 35 U.S.C. §119 to: 1) U.S.Provisional Patent Application 61/979,857, which was filed Apr. 15,2014, entitled “SACROILIAC JOINT IMPLANT”, 2) U.S. provisionalapplication 61/955,126, which was filed Mar. 18, 2014, entitled“SACROILIAC JOINT IMPLANT”, 3) U.S. Provisional Patent Application61/914,409, which was filed Dec. 11, 2013, entitled “SYSTEMS FOR ANDMETHODS OF FUSING A SACROILIAC JOINT”, and 4) U.S. Provisional PatentApplication 61/860,185, which was filed Jul. 30, 2013, entitled “SYSTEMSFOR AND METHODS OF FUSING A SACROILIAC JOINT”. The '612 application andall Provisional patent application's in which it claims priority to arehereby incorporated by reference in their entireties into the presentapplication.

TECHNICAL FIELD

Aspects of the present disclosure relate to medical apparatus andmethods. More specifically, the present disclosure relates to devicesand methods for preparing a sacroiliac joint for fusion.

BACKGROUND

The sacroiliac joint is the joint between the sacrum and the ilium ofthe pelvis, which are joined by ligaments. In humans, the sacrumsupports the spine and is supported in turn by an ilium on each side.The sacroiliac joint is a synovial joint with articular cartilage andirregular elevations and depressions that produce interlocking of thetwo bones.

Pain associated with the sacroiliac joint can be caused by traumaticfracture dislocation of the pelvis, degenerative arthritis, sacroiliitisan inflammation or degenerative condition of the sacroiliac joint,osteitis condensans ilii, or other degenerative conditions of thesacroiliac joint. Currently, sacroiliac joint fusion is most commonlyadvocated as a surgical treatment for these conditions. Fusion of thesacroiliac joint can be accomplished by several different conventionalmethods encompassing an anterior approach, a posterior approach, and alateral approach with or without percutaneous screw or other typeimplant fixation. However, while each of these methods has been utilizedfor fixation and fusion of the sacroiliac joint over the past severaldecades, substantial problems with respect to the fixation and fusion ofthe sacroiliac joint remain unresolved.

A significant problem with certain conventional methods for fixation andfusion of the sacroiliac joint including the anterior approach,posterior approach, or lateral approach may be that the surgeon has tomake a substantial incision in the skin and tissues for direct access tothe sacroiliac joint involved. These invasive approaches allow thesacroiliac joint to be seen and touched directly by the surgeon. Oftenreferred to as an “open surgery”, these procedures have the attendantdisadvantages of requiring general anesthesia and can involve increasedoperative time, hospitalization, pain, and recovery time due to theextensive soft tissue damage resulting from the open surgery.

A danger to open surgery using the anterior approach can be damage tothe L5 nerve root, which lies approximately two centimeters medial tothe sacroiliac joint or damage to the major blood vessels. Additionallyand as seen in FIG. 1, which depicts a conventional fusion procedure(immobilization of the articular surfaces of the sacroiliac joint inrelation to one another) on a sacroiliac joint 1, one or more screws orimplants 2 are implanted transversely across the articular surfaces 3and through the sacrum 4 and the ilium bones 5. That is, the joint 1 isimmobilized by placement of a fusion device 2 transverse to or across aplane defined by articular surfaces 3 of the sacroiliac joint space.

Use of trans-sacroiliac and S1 pedicle-iliac bone implants can alsoinvolve the risk of damage to the lumbosacral neurovascular elements.Damage to the lumbosacral neurovascular elements as well as delayedunion or non-union of the sacroiliac joint by use of these proceduresmay require revision surgery to remove all or a portion of the implantsor repeat surgery as to these complications.

Another significant problem with conventional procedures utilizingminimally invasive small opening procedures can be that the proceduresare technically difficult, requiring biplanar fluoroscopy of thearticular surfaces of the sacroiliac joint and extensive surgicaltraining and experience. Despite the level of surgical training andexperience, there is a substantial incidence of damage to thelumbosacral neurovascular elements. Additionally, sacral anomalies canfurther lead to malplacement of implants leading to damage ofsurrounding structures. Additionally, these procedures are oftenperformed without fusion of the sacroiliac joint, which does not removethe degenerative joint surface and thereby does not address thedegenerative condition of the sacroiliac joint, which may lead tocontinued or recurrent sacroiliac joint pain.

Another significant problem with conventional procedures can be theutilization of multiple trans-sacroiliac elongate implants, which do notinclude a threaded surface. This approach requires the creation oftrans-sacroiliac bores in the pelvis and nearby sacral foramen, whichcan be of relatively large dimension and which are subsequently broachedwith instruments, which can result in bone being impacted into thepelvis and neuroforamen.

The creation of the trans-sacroiliac bores and subsequent broaching ofthe bores requires a guide pin, which may be inadvertently advanced intothe pelvis or sacral foramen, resulting in damage to other structures.Additionally, producing the trans-sacroiliac bores, broaching, orplacement of the elongate implants may result in damage to thelumbosacral neurovascular elements, as above discussed. Additionally,there may be no actual fusion of the articular portion of the sacroiliacjoint, which may result in continued or recurrent pain requiringadditional surgery.

Another substantial problem with conventional procedures can be thatplacement of posterior extra-articular distracting fusion implants andbone grafts may be inadequate with respect to removal of the articularsurface or preparation of cortical bone, the implant structure andfixation of the sacroiliac joint. The conventional procedures may notremove sufficient amounts of the articular surfaces or cortical surfacesof the sacroiliac joint to relieve pain in the sacroiliac joint. Theconventional implant structures may have insufficient or avoidengagement with the articular surfaces or cortical bone of thesacroiliac joint for adequate fixation or fusion. The failure tosufficiently stabilize and fuse the sacroiliac joint with theconventional implant structures and methods may result in a failure torelieve the condition of sacroiliac joint being treated. Additionally,conventional methods of driving apart a sacrum and ilium may lead tomal-alignment of the sacroiliac joint and increased pain.

Improvements to sacroiliac joint fusion involve systems and methods fornon-transverse delivery of an implant into the sacroiliac joint aredescribed in U.S. patent application Ser. No. 12/998,712, filed May 23,2011 entitled SACROILIAC JOINT FIXATION FUSION SYSTEM; Ser. No.13/236,411, filed Sep. 19, 2011 entitled SYSTEMS FOR AND METHODS OFFUSING A SACROILIAC JOINT; and Ser. No. 13/475,695, filed May 18, 2012,entitled SYSTEMS FOR AND METHODS OF FUSING A SACROILIAC JOINT; and Ser.No. 13/945,053, filed Jul. 18, 2013, entitled SYSTEMS FOR AND METHODS OFFUSING A SACROILIAC JOINT; and Ser. No. 13/946,790, filed Jul. 19, 2013,entitled SYSTEMS FOR AND METHODS OF FUSING A SACROILIAC JOINT; and Ser.No. 14/216,975, filed Mar. 17, 2014, entitled SYSTEMS AND METHODS FORFUSING A SACROILIAC JOINT AND ANCHORING AN ORTHOPEDIC APPLIANCE; andSer. No. 14/447,612, filed Jul. 31, 2014, entitled SYSTEMS FOR ANDMETHODS OF FUSING A SACROILIAC JOINT. All of application Ser. Nos.12/998,712, 13/236,411, 13/475,695, 13/945,053, 13/946,790, 14/216,975,and Ser. No. 14/447,612 are herein incorporated by reference in theirentirety. In certain instances, it may be desirable to prepare thesurfaces of the sacroiliac joint prior to implantation of the fusiondevice, e.g., the intraarticular or extra-articular surfaces. Whilesurgical preparation tools may exist for procedures in other areas ofthe body, tools for preparing the sacroiliac joint for fusion arelacking. Thus, the systems and methods discussed herein address thechallenges in preparing the sacroiliac joint for fixation and fusion.

SUMMARY

One implementation of the present disclosure may take the form of asurgical preparation tool for preparing a sacroiliac joint having asacrum and an ilium for a surgical procedure. In one embodiment, thetool may include a trial tool assembly and a cutting tool.

The trial tool assembly may include an implant trial at a distal end ofthe trial tool assembly and a trial shaft coupled to and extendingproximally from the implant trial. The implant trial may include a bodycomprising a first length extending along a longitudinal axis from aproximal to a distal end, a top surface, a bottom surface generallyopposite the top surface, a first side surface, and a second sidesurface generally opposite the first side surface. The implant trial maybe configured to be delivered non-transversely into the sacroiliac jointsuch that the first top and first bottom surfaces oppose either thesacrum or the ilium.

The cutting tool of the surgical preparation tool may be configured toreleasably and slidably couple with the trial tool assembly. The cuttingtool may include a first cutting element at a distal end of the cuttingtool and a cutting shaft extending proximally from the cutting element.The first cutting element may include a second length extending from aproximal to a distal end. The trial tool assembly is configured to guidethe cutting tool during distal-proximal translation such that as thefirst cutting element distally advances relative to the implant trial,at least a portion of the first cutting element extends generally overand perpendicularly outward from the first side surface of the body ofthe implant trial.

Another implementation of the present disclosure may take the form of asurgical preparation tool for preparing a sacroiliac joint having asacrum and an ilium for a surgical procedure. In one embodiment, thetool may include a trial tool assembly and a drill guide assembly.

The trial tool assembly may include an implant trial at a distal end ofthe trial tool assembly and a trial shaft coupled to and extendingproximally from the implant trial. The implant trial may include a bodycomprising a first length extending along a longitudinal axis from aproximal to a distal end, a first top surface, a first bottom surfacegenerally opposite the first top surface, and a thickness definedbetween the first top and first bottom surfaces. The implant trial maybe configured to be delivered non-transversely into the sacroiliac jointsuch that the first top and first bottom surfaces oppose either thesacrum or the ilium.

The drill guide assembly may be configured to releasably and slidablycouple with the trial tool assembly. The drill guide assembly mayinclude a drill guide at a distal end of the cutting guide and a drillguide shaft extending proximally from the drill guide. The drill guidemay include a first passageway that is configured to guide a drill bitduring distal-proximal translation of the drill bit relative to thedrill guide assembly. The trial tool assembly may be configured to guidethe drill guide assembly during distal-proximal translation such that asthe drill guide distally advances relative to the implant trial, thedrill guide is positioned in an orientation to deliver the drill bitgenerally over at least a portion of the first top surface of the bodyof the implant trial.

Yet another implementation of the present disclosure may take the formof a method of surgically preparing a sacroiliac joint having a sacrumand an ilium for a surgical fusion procedure.

In one embodiment, the method may include approaching a sacroiliac jointspace with a joint preparation tool that may include an implant trialassembly and a cutting tool. The implant trial assembly may include animplant trial at a distal end of the joint preparation tool and animplant trial shaft extending proximally from the implant trial. Theimplant trial may include a length extending from a proximal end to adistal end of the implant trial, a first top surface, and a first bottomsurface generally opposite the first top surface. The cutting tool maybe configured to releasably and slidably couple with the trial toolassembly. The cutting tool may include a cutting element at a distal endof the cutting tool and a cutting shaft extending proximally from thecutting element. The cutting element may include a second lengthextending from a proximal to a distal end, wherein the trial toolassembly is configured to guide the cutting tool during distal-proximaltranslation.

The method may also include delivering a portion of the implant trialnon-transversely into the sacroiliac joint space. The implant trial maybe oriented in the sacroiliac joint space such that the first top andbottom surfaces are generally coplanar with a joint plane of thesacroiliac joint space.

The method may further include causing the cutting tool to be distallydriven relative to the trial tool assembly such that the cutting elementmakes a cut extending into the sacrum or the ilium.

Another implementation of the present disclosure may take the form of asurgical system for preparing a sacroiliac joint having a sacrum and anilium for a surgical procedure. In one embodiment, the system mayinclude a joint preparation tool and a first anchoring arm.

The joint preparation tool may include a rasping head at a distal end ofthe joint preparation tool, a shaft extending proximally from therasping head, and a longitudinal axis extending from a proximal to adistal end of the joint preparation tool. The rasping head may include alength extending from a distal to a proximal end of the rasping head, atop surface, and a bottom surface opposite the top surface.

The first anchoring arm may include a proximal end and a distal end,where the distal end of the first anchoring arm may be configured toengage a proximal end of an anchor element, the first anchoring arm maybe operably coupled to the joint preparation tool in an arrangement suchthat a longitudinal axis of the anchor element is generally transverselyaligned with the longitudinal axis of the joint preparation tool whenthe distal end of the first anchoring arm is engaged with the proximalend of the anchor element, wherein the first anchoring arm is configuredto deliver the anchor element across the sacroiliac joint according tothe arrangement.

Another implementation of the present disclosure may take the form of asurgical preparation tool for preparing a sacroiliac joint having asacrum and an ilium for a surgical procedure. In one embodiment, thetool may include a trial tool assembly and a cutting tool assembly.

The trial tool assembly may include an implant trial at a distal end ofthe trial tool assembly and a trial shaft coupled to and extendingproximally from the implant trial. The implant trial may include a bodycomprising a first length extending along a longitudinal axis from aproximal to a distal end, a first top surface, a first bottom surfacegenerally opposite the first top surface, and a thickness definedbetween the first top and first bottom surfaces. The implant trial maybe configured to be delivered non-transversely into the sacroiliac jointsuch that the first top and first bottom surfaces oppose either thesacrum or the ilium.

The cutting tool may be configured to releasably and slidably couplewith the trial tool assembly. The cutting tool may include a cuttingelement at a distal end of the cutting tool and a cutting shaftextending proximally from the cutting element. The cutting element mayinclude a second length extending from a proximal to a distal end. Thetrial tool assembly may be configured to guide the cutting tool duringdistal-proximal translation such that as the cutting element distallyadvances relative to the implant trial, at least a portion of thecutting element extends generally over and perpendicularly outward fromthe first top surface of the body of the implant trial.

While multiple embodiments are disclosed, still other embodiments of thepresent disclosure will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the disclosure. As will be realized, thevarious embodiments of the present disclosure are capable ofmodifications in various aspects, all without departing from the spiritand scope of the present disclosure. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an anterior view of the pelvic region and a conventionalmethod and device for stabilizing the sacroiliac joint.

FIG. 2A is an isometric view of a first embodiment of a system forfusing a sacroiliac joint.

FIG. 2B is the same view as FIG. 2A, except the delivery tool andimplant assembly are decoupled from each other.

FIG. 3 is the same view as FIG. 2A, except the system is exploded tobetter illustrate its components.

FIG. 4 is a posterior-inferior view of a sacroiliac joint with a patientbody shown in broken line.

FIG. 5 is a close-up view of the implant and anchor element in thesacroiliac joint.

FIG. 6 is an isometric view of a first embodiment of a joint preparationtool.

FIG. 7 is an exploded side view of the first embodiment of the jointpreparation tool.

FIG. 8 is an isometric and cross-sectional view of the first embodimentof the joint preparation tool.

FIGS. 9A-9B are isometric views of a cutting element at a distal end ofthe tooling head.

FIG. 10 is an isometric view of the proximal edge of the cuttingelement.

FIG. 11 is an isometric view of a tooling head with a closed distal endand an opened proximal end.

FIG. 12 is an isometric and cross-sectional view of the tooling head ofFIG. 11.

FIG. 13 is a side view of a tooling head with a pair of cutting elementsopposite each other.

FIG. 14A is a side view of the shaft of the tooling head and possiblemodifications.

FIG. 14B is a close-up side view of the distal end of the tooling headof FIG. 14A.

FIG. 15A is an isometric view of a tooling head with an ellipsoidalhead.

FIG. 15B is a side view of the tooling head with the ellipsoidal head.

FIG. 15C is a close-up side view of the tooling head with theellipsoidal head.

FIG. 15D is another side view of the tooling head with the ellipsoidalhead.

FIG. 16 is an isometric view of a tooling head with a bisectedellipsoidal head.

FIG. 17 is an isometric view of another tooling head with a bisectedellipsoidal head.

FIG. 18A is a front view of a tooling head with a planar rasping head.

FIG. 18B is a side view of the tooling head of FIG. 18A.

FIG. 18C is a side cross-sectional view of the planar rasping head.

FIG. 18D is a close-up isometric view of the planar rasping head.

FIG. 19A is a front view of a tooling head with a planar rasping headand a single perpendicularly extending cutting element.

FIG. 19B is a side view of the tooling head of FIG. 19A.

FIG. 19C is a side cross-sectional view of the planar rasping head andthe single perpendicularly extending cutting element.

FIG. 19D is a close-up isometric view of the planar rasping head and thesingle perpendicularly extending cutting element.

FIG. 20A is a front view of a tooling head with a smooth planar head anda single perpendicularly extending cutting element.

FIG. 20B is a side view of the tooling head of FIG. 20A.

FIG. 20C is a close-up isometric view of the smooth planar head and thesingle perpendicularly extending cutting element.

FIG. 21A is a front view of a tooling head with a smooth planar head anda pair of perpendicularly extending cutting elements.

FIG. 21B is a side view of the tooling head of FIG. 21A.

FIG. 21C is a close-up isometric view of the smooth planar head and thepair of perpendicularly extending cutting elements.

FIG. 22A is a front view of a tooling head with a planar rasping headand a pair of perpendicularly extending cutting elements.

FIG. 22B is a side view of the tooling head of FIG. 22A.

FIG. 22C is a side cross-sectional view of the tooling head of FIG. 22A.

FIG. 22D is a close-up isometric view of the planar rasping head and thepair of perpendicularly extending cutting elements.

FIG. 23A is a front view of a tooling head with a box osteotome head.

FIG. 23B is a side view of the tooling head of FIG. 23A.

FIG. 23C is a cross-sectional view of the box osteotome head.

FIG. 23D is a bottom close-up isometric view of the box osteotome head.

FIG. 24A is a side view of a surgical preparation tool attached to ananchor arm assembly.

FIG. 24B is a side view of the surgical preparation tool and the anchorarm assembly of FIG. 24A in a pre-assembled state.

FIG. 25 is a side view of another surgical preparation tool attached toan anchor arm assembly.

FIG. 26A is an isometric view of a joint preparation tool with atranslating and rotation inhibiting distal handle assembly.

FIG. 26B is a cross-sectional view of a coupler member and a shaft of atooling head of the tool of FIG. 26A.

FIG. 26C is a front isometric view of the joint preparation tool of FIG.26A with a socket assembly in an uncoupled state.

FIG. 26D is a side view of the joint preparation tool of FIG. 26A withthe distal handle assembly in a proximal position.

FIG. 26E is a close-up side view of a cutting element at a distal end ofthe tooling head of the joint preparation tool of FIG. 26A.

FIG. 26F is a cross-sectional view of the cutting element of FIG. 26E.

FIG. 26G is a cross-sectional view of another embodiment of a cuttingelement.

FIG. 27 is an isometric view of a bottom side of a surgical preparationtool assembly including a trial tool assembly and a cutting tool.

FIG. 28 is an isometric view of a top side of the surgical preparationtool assembly of FIG. 27.

FIG. 29 is an isometric view of the cutting tool of the surgicalpreparation tool assembly of FIG. 27.

FIG. 30 is a close-up isometric view of a distal end of the cuttingtool.

FIG. 31 is an isometric back view of the surgical preparation toolassembly with a cross-section at the proximal end of the implant trial.

FIG. 32 is a front view of the trial tool assembly.

FIG. 33 is a back view of the trial tool assembly.

FIG. 34 is a side view of the trial tool assembly.

FIG. 35 is a cross-sectional isometric view of the handle assembly andthe proximal end of the shaft of the trial tool.

FIG. 36A is a side view of another embodiment of a cutting tool.

FIG. 36B is a close-up isometric view of the cutting tool of FIG. 35A.

FIG. 36C is a side view of a cutting element formed of a chain ofinterconnected teeth.

FIG. 36D is a top view of an implant trial configured to guide thecutting element of FIG. 36C.

FIG. 36E is an isometric view of an arcuate implant trial configured toguide a cutting element formed of a chain of interconnected teeth.

FIG. 37 is an isometric view of a joint preparation tool assembly withcoaxially aligned shafts of a cutting tool and a trial implant toolassembly.

FIG. 38 is an isometric view of the joint preparation tool assembly ofFIG. 37 with the cutting tool and the trial implant tool assembly in anuncoupled state.

FIG. 39 is an isometric view of a joint preparation tool assembly withcoaxially aligned shafts of a cutting tool, a trial implant toolassembly, and a trial impact rod assembly.

FIGS. 40A-40C are isometric views of the trial impact rod assembly andthe trial tool assembly coupling together.

FIG. 41 is an isometric view of a handle assembly coupling with thetrial impact rod assembly and the trial tool assembly.

FIG. 42A is an isometric view of the cutting tool and the trial toolassembly coupling together.

FIG. 42B is an isometric view of the handle assembly coupling with thecutting tool and the trial tool assembly.

FIG. 43A-43D are front view of implant trials with differingconfigurations of cutting tools.

FIG. 43E is an isometric view of an implant trial and an anchor memberin a recessed condition.

FIG. 43F is an isometric view of an implant trial and an anchor memberin a deployed condition.

FIG. 44 is an isometric view of a joint preparation tool assembly with atrial tool assembly and a drill guide.

FIG. 45 is an isometric view of the joint preparation tool assembly ofFIG. 44 with the various components in an uncoupled state.

FIG. 46 is an isometric view of the joint preparation tool assembly ofFIG. 44 with a drill bit positioned within a collar of the drill guide.

FIG. 47A-47B are differing configurations of the collar on the drillguide.

FIG. 48A is a right lateral view of a hip region of a patient lying in aprone position, wherein the soft tissue surrounding the skeletalstructure of the patient is shown in dashed lines.

FIG. 48B is an enlarged view of the hip region of FIG. 48A.

FIG. 48C is generally the same view as FIG. 48B, except that the iliumis removed to show the sacroiliac joint space boundary defined along thesacrum and an implant positioned for implantation within the jointspace.

FIGS. 49A-49D are each a step in the methodology and illustrated as thesame transverse cross section taken along a plane extending generallymedial-lateral and generally anterior posterior.

-   -   FIG. 49E is a posterior view of the pelvic region showing fixed        placement of the cannula in relation to the sacroiliac joint        having inserted within a cannula alignment jig.    -   FIG. 49F is a perspective view of the cannula jig insert shown        in FIG, 49E having cross hairs.    -   FIG. 49G is a perspective view of the cannula shown in FIG. 49F        having a cannula alignment jig inserted within having alignable        cross hairs.    -   FIG. 49H is a posterior view of the pelvic region showing fixed        placement of the cannula in relation to the sacroiliac joint        having within a first drill jig.    -   FIG. 49I is a perspective view of the cannula of FIG. 49H having        within the first drill jig.    -   FIG. 49J is a side view of a cannula, in one embodiment.    -   FIG. 49K is a top view of the cannula of FIG. 49J.    -   FIG. 49L is a front view of the cannula of FIG. 49J.    -   FIG. 49M is a posterior lateral view of the pelvic region        showing the cannula of FIG. 49J positioned in relation to the        sacroiliac joint.    -   FIG. 49N is another posterior lateral view of the pelvic region        showing the cannula of FIG. 49J positioned in relation to the        sacroiliac joint.    -   FIG. 49O is a posterior view of the pelvic region showing the        cannula of FIG. 49J positioned in relation to the sacroiliac        joint.    -   FIG. 49P is a posterior inferior view of the pelvic region        showing the cannula of FIG. 49J positioned in relation to the        sacroiliac joint.    -   FIG. 49Q is a posterior view of the pelvic region showing the        cannula of FIG. 49J positioned in relation to the sacroiliac        joint.    -   FIG. 49R is another posterior view of the pelvic region showing        the cannula of FIG. 49J positioned in relation to the sacroiliac        joint.

FIGS. 50A-50B are steps in the methodology of preparing the sacroiliacjoint for fusion utilizing a tooling head, e g., of FIGS. 9-10, andillustrated in the transverse cross section of FIGS. 49A-49D.

FIGS. 50C-50F are additional steps in the methodology that continue fromthose described in reference to FIGS. 50A-50B, except that the view isof the sacroiliac joint from the perspective in FIG. 48C.

FIGS. 51A-51E are additional steps in the methodology of preparing thesacroiliac joint for fusion including utilizing a tooling head, e.g., ofFIGS. 9-10, and illustrated in the transverse cross section of FIGS.50A-50B.

FIGS. 52A-52B are steps in the methodology of preparing a sacroiliacjoint for fusion utilizing a tooling head with dual cutting elements,e.g., as seen in FIG. 13, and shown in the transverse cross section ofFIGS. 49A-49D.

FIGS. 53A-53D are steps in the methodology of preparing a sacroiliacjoint for fusion utilizing the joint preparation tool assembliesdescribed in FIGS. 27-47.

-   -   FIG. 54A-54E depict, respectively, an isometric view, top view,        side view, back view, and front view of a joint implant, in one        embodiment. The side view being the same as an opposite side        view, and the top view being the same as the bottom view.    -   FIG. 55A-55E depict, respectively, an isometric view, top view,        side view, back view, and front view of a joint implant, in one        embodiment. The side view being the same as an opposite side        view, and the top view being the same as the bottom view.    -   FIG. 56A is a side view of a telescoping anchor arm assembly.    -   FIG. 56B is a side view of the telescoping anchor arm assembly        of FIG. 56A, except with a portion of the first section nested        within the central lumen of the second section, resulting in a        shorter elongate shape.

DETAILED DESCRIPTION

Implementations of the present disclosure involve a system for preparinga sacroiliac joint for fusion. In particular, the system may include apreparation tool for removing articular cartilage from the sacroiliacjoint space, abrading of the articular surfaces to enhance boney fusion,and removal of portions of the cortical, subchondral or cancellous bonefor implantation of a fusion device. The preparation tool may include ananchoring arm that is configured to direct an anchoring element fortransverse delivery through the sacroiliac joint space. The anchor maybe delivered into the joint space before, during, or after the jointspace is prepared for implant delivery. Alternatively, an implant maynot be delivered into the joint and instead, e.g., bone paste or slurrymay be introduced into the prepared sacroiliac joint before or afteranchor placement. And, the anchor may be delivered cranial, caudal, orin-line with the eventual placement of the implant. The preparation toolis configured to quickly, accurately and reliably prepare the jointspace for insertion of an implant.

I. System for Fusion of the Sacroiliac Joint

To begin a detailed discussion of a system 10 for delivering an implant12 into the sacroiliac joint, reference is made to FIGS. 2A-3. FIG. 2Ais an isometric view of the system 10. FIG. 2B is the same view as FIG.2A, except an implant assembly 14 of the system 10 is separated from adelivery tool 16 of the system 10. FIG. 3 is the same view as FIG. 2A,except the system 10 is shown exploded to better illustrate thecomponents of the system 10.

As can be understood from FIGS. 2A and 2B, the system 10 includes adelivery tool 16 and an implant assembly 14 for implanting at thesacroiliac joint via the delivery tool 16, the implant assembly 14 beingfor fusing the sacroiliac joint. As indicated in FIG. 3, the implantassembly 14 includes an implant 12 and an anchor element 18 (e.g., abone screw or other elongated body). As discussed below in greaterdetail, during the implantation of the implant assembly 14 at thesacroiliac joint, the implant 12 and anchor element 18 are supported bya distal end 20 of the delivery tool 16, as illustrated in FIG. 2A. Thedelivery tool 16 is used to deliver the implant 12 into the sacroiliacjoint space. The delivery tool 16 is then used to cause the anchorelement 18 to extend through the ilium, sacrum and implant 12 generallytransverse to the sacroiliac joint and implant 12. The delivery tool 16is then decoupled from the implanted implant assembly 14, as can beunderstood from FIG. 2B. As illustrated in FIG. 3, the delivery tool 16further includes a proximal end 22 opposite the distal end 20, an armassembly 24, a handle 26, an implant retainer 28, a sleeve 30 and atrocar or guidewire 32. While in the embodiment of FIGS. 2A-3, thedelivery tool 16 is fixed and non-adjustable and configured to deliverthe anchoring element 18 in a single orientation relative to the implant12, the delivery tool 16 may be adjustable and configured to deliver theanchoring element 18 within a range of orientations relative to theimplant 12 that will orient the anchoring element 18 either within abore of the implant 12, or adjacent implant 12 as described in U.S.patent application Ser. No. 14/447,612, filed Jul. 31, 2014, entitledSYSTEMS FOR AND METHODS OF FUSING A SACROILIAC JOINT, which is herebyincorporated by reference in its entirety.

In particular embodiments, first and second articular faces of theimplant 12 may be selected to match the contour of the joint space ofthe sacroiliac joint within which the implant 12 is to be inserted. Forexample, the sacral, medial or first articular face of the implant maybe configured to be generally convex to match the contour of a sacralauricular boney surface or to match the contour of an extra-articularregion of a sacrum (e.g., a sacral fossa). In one aspect and referringto portions of the anatomy shown FIG. 48C, the sacral, medial or firstarticular face of the implant 12 may be generally a surface negative ofthe articular surfaces 1016 of the extra-articular region 3007 and/orarticular region 1044 of the sacrum 1004. As another example, thelateral, iliac or second articular face of the implant 12 may beconfigured to be generally concave to match the contour of an iliacauricular boney surface or to match the contour of an extra-articularregion of an ilium (e.g., an iliac tuberosity). In one aspect, thelateral, iliac or second articular face of the implant 12 may begenerally a surface negative of the articular surfaces 1016 of theextra-articular region 3007 and/or articular region 1044 of the ilium1005.

-   -   Referring to FIGS. 54A-54E, in one embodiment the implant 9010        includes a first planar member 9012 extending a first top length        of the implant and comprising a first planar top surface 9014        that extends between a first sacral side edge 9016 and a first        ilium side edge 9018 that is opposite of and substantially        parallel with the first sacral side edge, the side edges being        substantially perpendicular to first planar top surface, the        side edges extending the first top length of the implant and        disposed a first thickness 9020 from a first bottom surface 9022        that is opposite the first planar top surface, the first planar        top surface also extending between a substantially perpendicular        proximal end edge 9024 and a tapered distal end edge 9026, the        tapered distal edge including a sloped taper 9028 along the        first thickness between the first planar top surface and the        first bottom surface such that the first top length is shorter        than a first bottom length that extends a length of the first        bottom surface, the tapered distal edge also including an inward        tapering 9030 of the side edges towards a distal end of the        implant, the side edges including a taper 9032 at a proximal end        of the implant such that the first thickness substantially        linearly increases until the side edges meet with the proximal        end edge.    -   The implant further includes a second planar member 9034 that is        opposite the first planar member, the second planar member        extending a second top length of the implant and comprising a        second planar top surface 9036 that extends between a second        sacral side edge 9038 and a second ilium side edge 9040 that is        opposite of and substantially parallel with the second sacral        side edge, the side edges being substantially perpendicular to        the second planar top surface, the side edges extending the        second top length of the implant and disposed a second thickness        9042 from a second bottom surface 9044 that is opposite the        first planar top surface and opposed to the first bottom        surface, the second planar top surface also extending between a        substantially perpendicular proximal end edge 9046 and a tapered        distal end edge 9048, the tapered distal edge including a sloped        taper 9050 along the second thickness between the second planar        top surface and the second bottom surface such that the second        top length is shorter than a second bottom length that extends a        length of the second bottom surface, the tapered distal edge        also including an inward tapering 9052 of the side edges towards        the distal end of the implant, the side edges including a taper        9054 at a proximal end of the implant such that the second        thickness substantially linearly increases until the side edges        meet with the proximal end edge.    -   The implant further includes a distal end member 9056 that        couples the respective tapered distal end edges of the first        planar member and the second planar member, the distal end        member extending perpendicularly between the first planar member        and the second planar member and including a distal front edge        9058, a proximal edge 9060 opposite the distal front edge, and a        pair of distal end member side surfaces 9062 between the distal        front edge and the proximal edge, the proximal edge including a        width that is larger than a width of the distal front edge such        that the pair of distal end member side surfaces tapers or        narrows 9064 towards the distal front edge, the distal front        edge including a distal most point 9066 that slopes toward each        of the respective first planar top surface and the second planar        top surface, the sloping of the distal front edge smoothly        transitioning 9068 with the sloped taper between the first        planar top surface and the first bottom surface as well as the        sloped taper between the second planar top surface and the        second bottom surface, the distal front edge and the proximal        edge both defining radial curves 9069.    -   The implant further includes a proximal end member 9070 that        couples the respective proximal end edges of the first planar        member and the seond planar member, the proximal end member        including a proximal side 9072 that is in-line and parallel with        the first and the second proximal end edge and a distal side        9074 that is opposite the proximal side, the distal side        including a curve 9076 that is a mirror of the radial curve of        the proximal edge of the distal end member, the proximal end        member including an axial bore 9078 through the proximal end        member, the proximal end member being slightly larger and        including a similar shape to the axial bore, the axial bore        being threaded and configured to mate with an implant insertion        tool, wherein a bone graft or anchoring window 9080 is defined        between the proximal edge of the distal end member and the        distal side of the proximal end member, the window including a        stadium shape that extends perpendicularly through a        longitudinal axis of the implant, the window being adapted to        receive bone graft or an anchoring element to anchor the implant        to the articular surfaces.    -   In certain embodiments, the distal end member side edges and the        proximal edge meet at a corner where the corner is perpendicular        or rounded. Similarly, other meeting points between respective        edges can be straight edges (e.g., perpendicular) or rounded.    -   In still other embodiments, among other figures, the first        sacral side edge 9016 and the first ilium side edge 9018 taper        inward from the proximal end 9024 to the distal end 9026 of the        implant such that the first planar top surface 9014 and the        second planar top surface 9016 defines a truncated isosceles        triangle with the side edges forming sides of equal length.    -   While reference is made to the embodiment of the implant 9010 in        FIGS. 54A-54E, the reference numerals are similarly applicable        to the implant 9010 in FIGS. 55A-55E.

A system as described in FIGS. 2A-3 may be used in a surgical procedurevia a posterior approach, as seen in FIGS. 4-5. As can be understoodfrom FIG. 4, which is a posterior-inferior view of a sacroiliac joint 36with a patient 40 shown in broken line, the delivery tool 16 ispositioned to deliver the implant 12 into a caudal region 34 of thesacroiliac joint 36 and the anchoring element 18 through the ilium 5 andinto the bore 38 of the implant 12. Referring to FIG. 5, the implant 12and anchoring element 18 have been inserted into the caudal region 34 ofthe sacroiliac joint 36 and the delivery tool 16 has been removed.

With further reference to the boney anatomy shown in FIG. 48C, a systemas described herein may be used in a surgical procedure via an anteriorapproach (e.g., such that the surgical pathway includes traversing ananterior boundary segment 3004 and/or traversing an anterior-inferiorcorner 3010) and may further include positioning an implant into asacroiliac joint such that: 1) the implant longitudinal axis a) isgenerally parallel to a sacroiliac joint inferior boundary segment 3002,or b) points towards a posterior superior iliac spine, or c) pointtowards a posterior inferior iliac spine, or d) points toward asacroiliac extra-articular region; or, 2) the distal end of the implantgenerally lies within a) a caudal region of the sacroiliac jointarticular region, or b) an extra-articular portion of the sacroiliacjoint, or c) a cranial portion or cephlad region of the sacroiliac jointarticular region.

Additionally, a system as described herein may be used in a surgicalprocedure via an approach which includes a surgical pathway whichtransverses a sacroiliac joint inferior boundary segment 3002, e.g., asdescribed in U.S. patent application Ser. No. 13/945,053, filed Jul. 18,2013, entitled SYSTEMS AND METHODS OF FUSING A SACROILIAC JOINT, whichis hereby incorporated by reference in its entirety. A surgicalprocedure via this pathway may further include positioning an implantinto a sacroiliac joint such that: 1) the implant longitudinal axis a)is transverse to a sacroiliac joint inferior boundary segment 3002, orb) points towards a posterior superior iliac spine, or c) point towardsa posterior inferior iliac spine, or d) points toward a sacroiliacextra-articular region, or e) points towards a sacroiliac joint anteriorboundary segment 3004, or f) points towards either superior boundarysegment corner 3014 or 3012 or somewhere in-between; or, 2) the distalend of the implant generally lies within a) a caudal region of thesacroiliac joint articular region, or b) an extra-articular portion ofthe sacroiliac joint, or c) a cranial portion or cephlad region of thesacroiliac joint articular region.

Furthermore, in an aspect, an implant 12 may be inserted along agenerally arcuate path. Accordingly, a surgical preparation techniqueand tools may be utilized while operating in an arcuate path. Theimplant arcuate path may follow and generally match the surgicalpreparation arcuate path and the path arc may include a radius ofbetween approximately 3 cm to 6 cm. The portion of the path having anarcuate path including a radius of between approximately 3 cm to 6 cmmay reside substantially in the plane of the sacroiliac joint or in aplane in close proximity and generally parallel thereto. Furthermore,the arcuate path may generally or substantially reside in sacroiliacjoint articular region 1044. Additionally, an implant may be selectedfor use during the procedure which substantially matches the radius orcurvature of the arcuate or curved insertion path or surgicalpreparation path.

According to a particular aspect, after drilling or otherwise producingan opening through an ilium (or sacrum) leading toward or into asacroiliac joint, a sleeve may guide (alone or along with anothercannulated tool, e.g., a needle) a bone paste, bone marrow aspirate,stem cells, allograft or any biocompatible material or substance intothe sacroiliac joint space via a path with a trajectory which may begenerally transverse to the plane of the sacroiliac joint. The sleevemay be caused to form a seal with a bone defining the sacroiliac joint,e.g. the ilium. The seal may be created by impacting a proximal end ofsleeve which may, for example, cause the sleeve to slightly penetratethe cortex of the outer table of the ilium. Alternatively, a cannulatedtool such as a large gauge needle or tube may either be interference fitwithin a hole in the ilium or the needle or tube may have a threadeddistal end which may be threaded into the bore formed in the ilium. Aplunger or bone tamp may be forced through a sleeve to advance the bonepaste or other material into the sacroiliac joint space, adjacent/aroundthe implant and/or into the bone graft window of the implant.

Subsequently, an anchor such as a bone screw may be advanced via thesleeve into engagement with an opening formed in the ilium and drivenacross the sacroiliac joint and further into the sacrum. Alternatively,a bone plug may positioned into the opening formed in the ilium in orderto occlude the passageway between the outer cortex of the ilium and theimplanted bone paste or other material positioned which had bepositioned generally in the plane of the joint.

As such, the systems and methods described herein are directed topreparing the sacroiliac joint for surgical fusion procedures of thistype and others.

II. System for Preparing the Sacroiliac Joint for Fusion

Various surgical preparation tools and assemblies will be discussedherein. These tools and assemblies may be used by themselves or incombination with each other. Additionally, features of a particularembodiment are non-limiting and may be incorporated into any or allother embodiments without departing from the teachings in thisdisclosure.

A. Joint Preparation Tool with Interchangeable Heads

To begin a detailed discussion of the surgical preparation tools forpreparing a sacroiliac joint for a fusion, reference is made to FIG. 6,which is an isometric view of a first embodiment of a joint preparationtool 50 with interchangeable tooling heads 52. Each of the tooling heads52 described herein may be used by themselves, with one or moresubcomponents of tool 50, with the completed tool 50, or with any othertool of the systems disclosed herein or incorporated herein. As seen inthe figure, the joint preparation tool 50 includes a slap hammerassembly 54 and a cutting tool assembly 56. The slap hammer assembly 54includes a proximal handle 58 that translates distal-proximal on a shaft60. The cutting tool assembly 56 includes a distal handle 62. To betterillustrate the components of the joint preparation tool 50, reference ismade to FIG. 7, which is an exploded side view of the tool 50. As seenin the figure, a distal end 64 of the shaft 60 of the slap hammerassembly 54 is coupled to a proximal end 66 of a shaft 68 of the toolinghead 52 via a connector 70 having dual-female threaded ports 72. Thedistal end 64 of the shaft 60 and the proximal end 66 of the shaft 68have thread features 74 that correspond and engage with the dual-femalethreaded ports 72. In other embodiments, the connector 70 may includedual-male threaded ends and the shafts 60, 68 may include correspondingfemale threaded ports. The distal handle 62 includes a lumen 76extending through the handle 62 that is slightly larger than an outerdiameter of the shaft 68 of the tooling head 52. The distal handle 62may be slidably positioned over the shaft 68 of the tooling head 52 andlocked in place with a pair of set screws 78. Thus, the distal handle 62may be positioned as far proximally such that it abuts the connector 70,as far distally so as not to interfere with the distal end of thetooling head 52, or at any point in between.

Reference is now made to FIG. 8, which is an isometric andcross-sectional view of the first embodiment of the joint preparationtool 50. As seen in the figure, the proximal handle 58 further includesa lumen 80 extending through the handle 58 that is slightly larger thanan outer diameter of the shaft 60 of the slap hammer assembly 54. Theproximal handle 58 is configured to slide or translate distal-proximalon the shaft 60 between a proximal stop feature 82 and a distal stopfeature 84. In this way, a surgeon may grasp the distal handle 62 withone hand and the proximal handle 58 with the other hand. To facilitatedistal driving of the tooling head 52, the surgeon may distally slidethe proximal handle until it makes contact with the distal stop feature84. The contact with the stop feature 84 will cause a force to betransmitted down the shaft 68 of the tooling head 52 such that head 52will advance in the direction of the force. This type of driving of thetooling head 52 may be useful to advance a distal end 86 of the toolinghead 52 into the sacroiliac joint.

Additionally, the proximal stop feature 82 may be configured such thatan additional handle may be coupled to or integral with proximal stopfeature 82. The additional handle may be in-line with shaft 60 andextend proximally from the proximal stop feature 82.

To facilitate backing-out of the tooling head 52, the surgeon mayproximally slide the proximal handle until it makes contact with theproximal stop feature 82. This contact will cause a force to betransmitted proximally, which may aid in backing the tooling head 52 outfrom within the sacroiliac joint, for example.

As stated above, the first embodiment of the joint preparation tool 50is configured to be used with a variety of interchangeable tooling heads52. In certain embodiments and referring to FIGS. 9A-9B, the toolinghead 52 may include a cutting element 88 at the distal end 86 of thetooling head 52. The cutting element 88 includes an aperture 90 at adistal most end of the tooling head 52 that extends between a distaledge 92 and a proximal edge 94. The distal edge 92 forms a boundary ofthe aperture 90 and, in this embodiment, the distal edge 92 is blunt.Opposite the distal edge 92 is the proximal edge 94, which, in thisembodiment, is angled, sharp, and configured for cutting during“backing-out” of the preparation tool 50 from the sacroiliac joint.

In this embodiment, the aperture 90 is rectangular and is defined by apair of generally parallel sidewall members 102 that extend generallytangentially from the surface of the shaft 68 of the tooling head 52.Adjacent and extending generally perpendicular between the parallelsidewall members 102 is a top wall member 104. Opposite the top wallmember 104 is an inner wall member 106 that may communicate with anopened end of a lumen 108 that extends through the shaft 68 of thetooling head 52. Additional tooling (e.g., guidewire, suctioning device,irrigation, a (centreless/shaftless/flexible/etc.) screw conveyor, anauger, Archimedes' screw, or their various combinations) may communicatethrough the lumen 108 for interaction with the portion of the patient'sbody in contact with the distal end 86 of the tooling head 52.

A tooling head 52 with a cutting element 88 as described in FIGS. 9A-9Bmay be useful, for example, during the initial preparations of thesacroiliac joint. That is, the cutting element 88 may be initially andcarefully advanced into the sacroiliac joint via the slap hammerassembly 54. Once at an appropriate depth into the caudal region of thejoint, the cutting element 88 may be more aggressively backed-out by theapplication of force by the proximal handle 58 against the proximal stopfeature 82. In this way, the force used to cut the articular cartilageis applied in the safer, proximal direction. Applying force distallyrequires care because advancement of the cutting element 88 too far(i.e., outside of the sacroiliac joint) can risk damage to, for example,the ventral sacroiliac joint ligament or the neurovascular structures inproximity to the joint.

Other arrangements of the cutting element 88 are possible andcontemplated by this disclosure. For example, the distal edge 92 may besharp and configured for cutting, while the proximal edge 94 may beblunt. Additionally and as seen in FIG. 10, which is an isometric viewof the proximal edge 94 of the cutting element 88, the side wall members102 are parallel, but the top wall member 104 and, thus, the distaledge, 92, the proximal edge 94, and the aperture 90 are rounded. As seenin the figure, the proximal edge 94 is sharpened along its radial edge96 and is configured to cut during a “backing-out” of the cuttingelement 88.

Other arrangements of the top wall member 104 and side wall members 102are possible. For example, the side wall members 102 may converge to ablade-like point. The particular arrangement of the top wall member 104and side wall members 102 may be chosen based on the density of theboney surface to be prepared. And, as will be discussed later, the tool50 may be used oriented perpendicular to the articular surfaces of thesacroiliac joint in order to make “keel-cuts” into the bone of either orboth of the sacrum or the ilium. Such keel-cuts may match or generallymatch a shape of an implant to be implanted into the joint.Alternatively, the keel-cuts may be sized smaller than portions of animplant to be implanted into the joint such that a portion of theimplant when implanted may extend beyond the keel-cut void and furtherinto the prepared bone. Alternatively, a keel-cut may be created in onlyone bone, for example, the ilium, and may generally match the shape ofan implant to be implanted while the second bone, e.g., the sacrum, mayhave no keel-cut or a keel-cut which is significantly undersized incomparison to the shape or size of the feature of the implant which isto be implanted into the sacrum. Thus, the shape of the top wall member104 and the side wall members 102 may be influenced by the type andconfiguration of the implant that is chosen for the fusion procedure.

Referring now to FIG. 11, which is an isometric view of anotherembodiment of a tooling head 52, the head 52 may include a curette-typeclosed distal end 86 and an opened proximal end 98 that defines acup-shape. The tooling head 52 may include a pair of generally parallelside wall members 102 and a rounded top wall member 104. A proximal edge94 bounds the opened proximal end 98 and may or may not be sharpened. Asbest seen in FIG. 12, which is an isometric and cross-sectional view ofthe tooling head 52, the tooling head 52 defines an inner cavity 100that is configured to gather cartilage or other material when scoopingor backing the distal end 86 of the tooling head 52 out of thesacroiliac joint. While not depicted in this embodiment, the toolinghead 52 may include an opening in the vicinity of the cavity 100 thatcommunicates with a lumen that extends through the shaft 68 of thetooling head 52. In certain instances, it may be advantageous to use thecup-shaped tooling head 52 of FIGS. 11-12 to gather and removebiological material that was cut or abraded from the articular surfacesof the sacroiliac joint by the opened tooling head 52 of FIGS. 9-10. Inother instances, however, the closed tooling head 52 of FIGS. 11-12 maybe used without previous preparation of the joint.

Referring now to FIG. 13, which is a side view of another embodiment ofthe tooling head 52, the head 52 may include two cutting elements 88opposite each other. Each cutting element 88 may be as described withreference to FIGS. 9A-9B, FIG. 10 or FIGS. 11-12. In particular, eachcutting element 88 includes parallel side wall members 102, a top wallmember 104 extending generally perpendicular between the parallel sidewall members 102, a distal edge 92, a proximal edge 94 opposite thedistal edge 92, and an aperture 90 extending between the distal andproximal edges 92, 94. In this embodiment, the distal edge 92 is bluntand the proximal edge 94 is sharpened such that the tooling head 52 isconfigured to cut or abrade cartilage or other material in thesacroiliac joint during backing-out of the tooling head 52 from thejoint. An arrangement with two cutting elements as shown in FIG. 13 maybe useful, for example, to prepare the plane of the joint as well as inmaking parallel side-cuts or keel-cuts into the surfaces of the iliumand sacrum. To prepare the plane of the joint, each of the cuttingelements 88 may be oriented such that neither projects into the sacrumor the ilium. Rather, the cutting elements 88 are oriented verticallywithin the articular space. On the other hand, to prepare the sacrumand/or the ilium for a subsequent delivery of an implant, the cuttingelements 88 may be oriented to project into the bone of the sacrum andilium, and for example oriented perpendicularly with the plane of thejoint such that the cutting elements protrude generally perpendicularlyinto the sacrum and the ilium to make cuts that match a shape of aportion of an implant that will be implanted in the joint.

Referring to FIG. 14A, which is a side view of a tooling head 52, theshaft 68 may include a gradual taper from the proximal end 66 of thetooling head 52 to the distal end 86. As seen in the figure, the shaft68 extends along a straight longitudinal axis between the distal andproximal ends 86, 66. Other arrangements of the shaft 68, however, arepossible. For example and as seen in FIG. 14A, the shaft 68 may includea dogleg 110 along the shaft 68. In this example, the distal andproximal ends 86, 66 of the shaft 68 extend along parallel axes, but amid-portion 112 of the shaft 68 extends non-parallel to the distal andproximal ends 86, 66. The dogleg 110 at the mid-portion 112 of the shaft68 defines an angle A between the proximal end 66 and the dogleg 110 andan angle B between the dogleg 110 and the distal end 86 of the shaft 68.Also, the proximal end 66 and distal end 86 may be offset by a distanceD1, which, in certain instances, may be within a range of about 10 mm toabout 25 mm or from about 15 mm to 70 mm. In certain embodiments, angleA may be within a range of about 90 degrees to about 165 degrees or fromabout 120 degrees and 150 degrees, and angle B may be within a range ofabout 90 degrees to about 165 degrees or from about 120 degrees and 150degrees.

Referring to FIG. 14B, which is a close-up of the distal end 86 of thetooling head 52, a distance D2 is defined between the top wall member104 and an opposite radial edge 114 of the shaft 68 of the tooling head52. In certain instances, distance D2 may be within a range of about 4mm to about 5.5 mm, from about 4.5 mm to about 6 mm, from about 5 mm toabout 6.5 mm, from about 5.5 mm to about 8 mm, from about 7.5 mm toabout 10 mm, from about 9 mm to about 11.5 mm and from about 11 mm toabout 15 mm. A distance D3 is defined by a length of the top wall memberand in certain instances D3 may be within a range of about 1.5 mm toabout 2.5 mm, from about 2 mm to about 3.5 mm, from about 3 mm to about4.75 mm, from about 4.25 mm to about 6 mm, from about 5 mm to about 6.75mm, from about 5.5 mm to about 8 mm, from about 7.5 mm to about 10 mm,from about 9 mm to about 11.5 mm and from about 11 mm to about 15 mm.Angle C is defined between the shaft 68 of the tooling head 52 and theextension of the proximal edge 94 of the side wall member 102. Incertain instances, angle C may be within a range of about 15 degrees toabout 35 degrees, from about 30 degrees to about 45 degrees, from about40 degrees to about 65 degrees, from about 60 degrees to about 75degrees, from about 70 degrees to about 100 degrees, from about 90degrees to about 135 degrees, from about 120 degrees to about 155degrees, from about 150 degrees to about 170 degrees, from about 160degrees to about 175 degrees, and from about 170 degrees to about 180degrees (e.g., substantially in-line with shaft 68).

As stated above, the first embodiment of the joint preparation tool 50is configured to be used with a variety of interchangeable tooling heads52. Additionally, the tooling heads 52 may be used independently fromthe joint preparation tool 50. In certain embodiments and referring toFIGS. 15A-15D, the tooling head 52 may include an elongate shaft 116coupled with an ellipsoidal head 118 at a distal end 120 of the toolinghead 52. A proximal end 119 of the tooling head 52 may include threading(not shown) in order to couple with the connector 70 of the jointpreparation tool 50 described previously. In this embodiment, theellipsoidal head 118 is a triaxial ellipsoid shape (semi-axes lengthsC>B>A), however, the head 118 may be other shapes without departing fromthe teachings of this disclosure. As seen in the figures, the ellipsoidhead 118 includes a rasp band 122 around one half of the circumferenceof the ellipsoid head 118. The rasp band 122 may include a rough surfacetexture, or geometrically repeating or non-repeating pattern that isconfigured to abrade a boney surface of a patient (e.g., articularsurface of the sacroiliac joint). In this particular embodiment, therasp band 122 is a repeating cone-shaped pattern that is in the plane ABbut is bounded on one side by axis A. While no rasp band 122 is depictedon the opposite side of the ellipsoid head 118, such a side may includea similar or different type of rasp band 122. For example, a less roughor “less aggressive” rasp band 122 may be included on the side oppositeof the current rasp band 122 or simply on one half of the currentlydepicted rasp band 122. In this way, the tooling head 52 may be used tosimultaneously rasp two surfaces with different rasp bands 122. Inpractice, such a tooling head 52 may be used to abrade the surfaces ofthe sacrum and the ilium in preparation for delivery of a joint implant.Since the sacrum is generally a softer bone than the ilium, the sacrummay require less abrasion than the ilium. Thus, the tooling head 52 withthe ellipsoid head 118 having rasp bands 122 of differing roughness onopposite sides of the head 118 may be beneficial to rasp the illium witha rasp band 122 having greater roughness and the sacrum with a rasp band122 having less or no roughness.

Reference is now made to FIGS. 16-17, which are isometric views oftooling heads 52 with bisected ellipsoidal heads 124 and bisected shafts126. The bisected ellipsoidal head 124 includes an ellipsoid shapedsurface 128 on one side and a planar surface 130 opposite the ellipsoidshaped surface 128. The planar surface 130 extends a length of the shaft126 from a distal end to a proximal end 120, 119. In FIG. 16, thebisected ellipsoidal head 124 includes a small rasp band 132 on aportion of the intersection of the planar surface 130 and theellipsoidal shaped surface 128. In this embodiment, the small rasp band132 includes a single row of teeth or other geometrically repeatingpattern; however, the small rasp band 132 may include other surfacesconfigured to abrade or rasp a surface. In FIG. 17, the bisectedellipsoidal head 124 includes a rasp band 134 that is similar to that asdescribed in FIGS. 15A-15D. That is, the rasp band 134 wraps around theentirety of the ellipsoid shaped surface 128 and includes a roughsurface texture, or geometrically repeating or non-repeating patternthat is configured to abrade a boney surface of a patient (e.g.,articular surface of sacroiliac joint). This type of tooling head 52 maybe useful, for example, when a single surface of a pair of opposedsurfaces requires rasping. As such, the tooling head 52 may be used, forexample, to rasp the ilium only while orienting the planar surface 130generally parallel with a plane defined by the sacrum. Alternatively,the tooling head 52 may be oriented to rasp the sacrum while orientingthe planar surface 130 in-line with the ilium.

Moving on, the discussion will focus on FIGS. 18-23 and additional typesand configurations of tooling heads 52 that are applicable for use withthe joint preparation tool 50. Additionally and as discussed previously,the tooling heads 52 discussed herein may also be used independentlyfrom the joint preparation tool 50.

Reference is now made to FIGS. 18A-18D, which depict a tooling head 52with a planar rasping head 136 at a distal end 138. The planar raspinghead 136 is configured to prepare a joint or boney surface forsubsequent delivery of an implant. More particularly, the planar raspinghead 136 may be used to abrade or roughen a joint surface, such as thesacroiliac joint, by removing cartilage from the joint and causing theboney surface of the sacrum and the ilium to hemorrhage, which maycontribute to subsequent bone growth and fusion of the sacrum and theilium.

As seen in the FIGS. 18A-18B, the planar rasping head 136 is coupled toa shaft 140 that extends to a handle 142 at a proximal end 144 of theshaft 140. A proximal end 146 of the handle 142 includes an impact plate148 that is configured to be struck with a hammer, mallet, or otherdevice in order to drive the planar rasping head 136 distally. Whilethis embodiment is depicted with a handle 142 attached to the proximalend 144 of the shaft 140, the shaft 140 could, alternatively, be coupledto the connector 70 of the joint preparation tool 50 describedpreviously.

As seen FIGS. 18A-18D, the planar rasping head 136 is a planar memberthat includes a pair of planar surfaces 150 opposite of and generallyparallel to each other. Alternatively, the pair of planar surfaces 150may be non-parallel (not shown) and may taper. The planar surfaces 150are disposed between a side edge 152 that wraps around the planarrasping head 136. A distal tip 158 of the planar rasping head 136 isrounded, although, in other embodiments, the distal tip may be pointed,flat, or otherwise. The planar rasping head 136 includes a raspingsurface 154 on the planar surfaces 150 and the side edge 152. Therasping surface 154 may include ridges 156 in a chevron pattern, as seenin the figures, or other surfaces configured to roughen or abrade abiological surface. The rasping surface 154 may, for example, includegeometrically repeating or non-repeating features (e.g., cones,pyramids, bubbles, spines, notches, teeth) formed by machining, surfacetreating, or otherwise.

As seen in FIG. 18A, the planar rasping head 136 may include a width W18in a range of about 13 mm to about 19 mm. In certain instances, thewidth W18 may be 13 mm, 16 mm, or 19 mm. As seen in FIG. 18B, the planarrasping head 136 may include a thickness T18 between the planar surfaces150 in a range of about 5 mm to about 7 mm. In certain instances, thethickness T18 may be 5 mm, 6 mm, or 7 mm.

Moving on, reference is made to FIGS. 19A-19D, which depict a toolinghead 52 with a planar rasping head 160 at a distal end 162 of thetooling head 52 that includes a single perpendicularly extending cuttingelement 164. The planar rasping head 160 is a planar member thatincludes a planar top surface 166, a planar bottom surface 168 oppositethe top surface 166, and a side edge 186 extending between the top andbottom surfaces 166, 168. The distal end 162 of the rasping head 160includes a double chamfered tip 184. Both the top and bottom surfaces166, 168 and the side edge 168 include a rasping surface 170 that isconfigured to abrade or roughen a boney surface or a joint. The raspingsurface 170 may include a series of ridges 172 in a chevron pattern orotherwise, as described previously. The tooling head of this embodimentmay also include a handle 142, an impact plate 148, and a shaft 140,among other features, as described in previous embodiments.

As seen in the figures, the cutting element 164 extends generallyperpendicularly upward from a central portion of the top surface 166.The cutting element 164 is a planar member with opposite side surfaces174 and a top surface 176 that includes a cutting element feature 178,which, in this embodiment, includes a series of teeth 180 with a roundedblade-tip 182 at the distal most end. The planar rasping head 136 isconfigured to prepare a joint or boney surface for subsequent deliveryof an implant. More particularly, the bottom surface 168 of the planarrasping head 136 may be used to abrade or roughen a joint surface, suchas the sacroiliac joint, by removing cartilage from the joint andcausing the boney surface of the sacrum and the ilium to hemorrhage,which may contribute to subsequent bone growth within the joint space.The top surface 166 with the cutting element 164, on the other hand, maybe used to cut into either the sacrum or the ilium in order to make wayfor a portion of an implant (e.g., keel or wing member) that willprotrude into the bone of the sacrum or ilium. As previously describedwith reference to FIG. 5, an implant may include keels that extendgenerally perpendicularly into each of the ilium and the sacrum. Thus, atooling head 52 such as seen in FIGS. 19A-19D may be useful in preparinga “keel-cut” into either or both of the sacrum or ilium such that whenthe implant 12 is delivered into the sacroiliac joint, the keels may bedelivered and positioned within the keel-cuts made by the tooling head52 with the planar rasping head 160 with the perpendicularly extendingcutting element 164. While the tooling head 52 is described with asingle perpendicularly extending cutting element 164, the head 52 mayinclude a second cutting element (not shown) extending opposite thefirst cutting element 164 on the bottom surface 168 of the rasping head160. In this way, the tooling head 52 may perform dual keel-cutssimultaneously in both the sacrum and the ilium. In such an embodiment,the cutting element feature 178 may be different for each cuttingelement 164 since the ilium is a generally harder bone than the sacrum,which is generally softer.

As seen in FIG. 19A, the planar rasping head 160 may include a width W19in a range of about 11 mm to about 17 mm. In certain instances, thewidth W19 may be 11 mm, 14 mm, or 17 mm. Also seen in FIG. 19A, thecutting element 164 may include a thickness T19A of about 2.5 mm. Asseen in FIG. 19B, the planar rasping head 160 may include a thicknessT19B between the planar surfaces 166, 168 in a range of about 5 mm toabout 7 mm. In certain instances, the thickness T19B may be 5 mm, 6 mm,or 7 mm. Also as seen in FIG. 19B, the planar rasping head 160 and thecutting element 164 may have a combined thickness TC19B in a range ofabout 5.5 mm to about 7.5 mm. In certain instances, the combinedthickness TC19B may be about 5.5 mm, 6.5 mm, or 7.5 mm.

Moving on, reference is made to FIGS. 20A-20C, which depict a toolinghead 52 with a planar rasping head 160 at a distal end 162 of thetooling head 52 that includes a single perpendicularly extending cuttingelement 164. This embodiment includes similar features to the toolinghead 52 described in reference to FIGS. 19A-19D, except that the presentembodiment includes a smooth surface 188 instead of a rasping surface onthe top surface, bottom surface, and side edges 166, 168, 186. Thepresent embodiment of the tooling head 52 may be useful in a surgicalpreparation when the articular surfaces of the sacroiliac joint need notbe rasped, but merely require keel-cuts into the sacrum and/or the iliumin preparation for delivery of an implant.

Reference is now made to FIGS. 21A-21C, which depict a tooling head 52with a planar rasping head 190 with a pair of perpendicularly extendingcutting elements 192 extending from side edges 194 of the head 52. Inthis embodiment, the planar rasping head 190 is a planar member thatincludes a planar top surface 196, a planar bottom surface 198 oppositethe top surface 196, both of which include a smooth surface texture 200.The planar rasping head 190 also includes a double chamfered tip 202 ata distal end 204 of the rasping head 190. Tip 202 may terminate distallyin-line with the chamfered tip of cutting element 216. Alternatively,tip 202 may extend a distance distally beyond the distal most portion ofthe chamfered tip of cutting element 216, for example, said distance maybe from about 1.5 mm to about 2.5 mm, from about 2 mm to about 3.5 mm,from about 3 mm to about 4.75 mm, from about 4.25 mm to about 6 mm, fromabout 5 mm to about 6.75 mm, from about 5.5 mm to about 8 mm, from about7.5 mm to about 10 mm, from about 9 mm to about 11.5 mm and from about11 mm to about 15 mm which may permit placement of a tip 202 within theplane of the joint thereby aligning cutting elements 192 to projecttoward or into the bone of the sacrum or ilium. Each of the cuttingelements 192 includes an inner surface 206 that faces the smooth surfacetexture 200, an outer surface 208 opposite the inner surface 206 that issmooth and lies flush with the side edge 194, and a top surface 210 thatincludes a cutting element feature 212 that includes a series of teeth214. A distal end of the cutting elements 192 includes a chamfered tip216. Additionally, the tooling head 52 of the present embodiment mayhave similar features as described in the previous embodiments. Thedimensions of the present embodiment may be similar to that as describedin reference to FIGS. 19A-19D.

Such a tooling head 52 with a pair of cutting elements 192 may be usedto perform dual keel-cuts in either or both of the ilium and sacrum fordelivery of an implant with dual keels such as described in U.S. patentapplication Ser. No. 14/447,612, filed Jul. 31, 2014 and entitledSYSTEMS FOR AND METHODS OF FUSING A SACROILIAC JOINT, which is herebyincorporated by reference in its entirety. To prepare the sacroiliacjoint for delivery of a dual keel implant, the tooling head 52 with thepair of cutting elements 192 may be inserted into the sacroiliac jointof a patient with the cutting elements oriented towards the ilium, forexample, and the tooling head 52 may be advanced distally in the caudalregion of the joint such that the cutting elements 192 cut into theboney surface of the ilium. Once at a far end of the caudal region, thetooling head 52 may be proximally withdrawn and repeated if desired.After sufficiently cutting into the ilium, the tooling head 52 may bewithdrawn from the joint. Next, the tooling head 52 may be rotated onehundred and eighty degrees such that the cutting elements are orientedtowards the sacrum. The tooling head 52 may then be advanced into thesacroiliac joint and make keel-cuts into the sacrum as describedpreviously with reference to the ilium. Once the tooling head 52 isremoved from the joint, the implant may then be delivered into the jointsuch that the implant keels are positioned within the keel-cuts madewith the cutting elements 192 of the tooling head 52.

Continuing on, reference is made to FIGS. 22A-22D, which depict atooling head 52 with a planar rasping head 190 at a distal end 204 ofthe tooling head 52 that includes a pair of perpendicularly extendingcutting element 192. This embodiment includes similar features to thetooling head 52 described in reference to FIGS. 21A-21C, except that thepresent embodiment includes a rasping surface 218 instead of a smoothsurface on the top and bottom surface 196, 198 of the rasping head 190.The rasping surface 218 may be as described previously and may include aseries of ridges 220 in a chevron pattern. A planar rasping head 190 ofthis embodiment may be useful for simultaneously rasping theintra-articulating surfaces of the sacroiliac joint to remove cartilageor abrade the boney surfaces and make dual keel-cuts into either thesacrum or the ilium for the subsequent delivery of an implant havingsimilarly featured keels.

Reference is now made to FIGS. 23A-23D, which depict a tooling head 52with a box osteotome head 222. As seen in the figures, the box osteotomehead 222 includes a planar top member 224, a planar bottom member 226generally parallel to and opposite of the planar top member 224, a pairof side members 228 that extend generally perpendicularly between thetop and bottom members 224, 226, and a pair of coaxially alignedopenings 230 in the top and bottom members 224, 226. In this embodiment,the openings 230 are bounded by four edges 236; however, theconfiguration of the openings 230 may include a different number ofedges 236 and shapes. The box osteotome head 222 defines a cavity 232therein that is bounded by inner surfaces 242 of the top, bottom, andside members 224, 226, 228. The cavity 232 is open on a distal end 234of the box osteotome head 222. A distal edge of the distal end 234 ofeach of the top, bottom, and side members 224, 226, 228 form a curvedcutting edge 238 that includes an inward bevel 240 such that outersurfaces 244 of the members 224, 226, 228 extend further distally thanthe inner surfaces 242.

As seen in the figures, the tooling head 52 additionally includes ashaft 246 that is four-sided, a handle 248 coupled to a proximal end 250of the shaft 246, and an impact plate 252 at a proximal end 254 of thehandle 248. The tooling head 52 of this embodiment may additionallyinclude features as described in the previous embodiments withoutlimitation.

The box osteotome head 222 may be useful in a surgical procedure where asection of bone or cartilage is to be removed. The box osteotome head222 may be distally advanced into the sacroiliac joint and bone and/orcartilage in contact with the cutting edge 238 will be cut and urged viathe inward bevel 240 within the cavity 232. After an appropriate cut hasbeen made, the box osteotome head 222 may be proximally removed from thejoint space and the biological material within the cavity 232 may beremoved through one or both of the coaxially aligned openings 230 in thetop and bottom members 224, 226. The box osteotome head 222 may be usedwith the joint preparation tool 50, as described previously, orindependently.

As seen in FIG. 23A, the box osteotome head 222 may include a width W23in a range of about 13 mm to about 19 mm. In certain instances, thewidth W23 may be 13 mm, 16 mm, or 19 mm. As seen in FIG. 23B, the boxosteotome head 222 may include a thickness T23 between the outersurfaces 244 of the top and bottom members 224, 226 in a range of about5 mm to about 7 mm. In certain instances, the thickness T23 may be 5 mm,6 mm, or 7 mm.

With reference to FIG. 23C, the shape of cavity 232 may generally matchthe shape of the implant which may be subsequently implanted into thevoid created by the head 222. In certain aspects, the cross sectionalshape and dimensions of the cavity 232 may substantially match thecorresponding cross sectional shape and dimensions of the implant to beimplanted at the joint in the void created by head 222.

B. Joint Preparation Tool with Anchoring Arm

Reference is now made to FIG. 24A, which is a side view of a firstembodiment of a joint preparation tool 256 attached to an anchoring armassembly 258. The anchoring arm assembly 258 may be similar to asdescribed in U.S. patent application Ser. No. 14/447,612, mentionedpreviously, and hereby incorporated by reference in its entirety. Thejoint preparation tool 256 may be similar to those described previouslyand may include a tooling head 260 as also described previously. As seenin FIG. 24A, the tooling head 260 includes a rasping head 284 with apair of perpendicularly extending cutting elements 262 extending fromside edges of the head 260. The tooling head 260 is attached to a handle286 at a proximal end of the tool 256. Regarding the anchoring armassembly 258, it includes an extension member 264 that extends from thejoint preparation tool 256. A distal portion of the extension member 264includes a pair of guide collars 272 that are configured to securelysupport and position an anchoring tool 274. The anchoring tool 274includes a tubular shaft 276 that is secured within the guide collars272 via a set screw 278. The anchoring tool 274 further includes arotationally engaged handle 280 at a proximal end of the tool 274 thatis configured to rotationally extend and retract an anchoring element282 that is coupled to a distal portion of the tool 274. The anchoringarm assembly 258 is configured to orient the anchoring element 282 in asingle orientation relative to the rasping head 284. That is, theanchoring arm assembly 258 or, more particularly, the orientation of theguide collars 272 relative to the rasping head 284 is fixed andnonadjustable once the anchoring arm assembly 258 is affixed to thejoint preparation tool. In this and other embodiments, the orientationof the anchoring element 282 may be such that, when delivered into thejoint space, the anchoring element 282 will be positioned cranial(above) to the rasping head 284, caudal (below) to the rasping head 284,or in-line with and distally of the rasping head 284.

Turning to FIG. 24B, reference is made to a pre-assembled state of thejoint preparation tool 256 and the anchoring arm assembly 258. As seenin the figure, the extension member 264 is coupled to and extends from asleeve 266 that includes a lumen extending therethrough. The sleeve 266is configured to receive a shaft 268 of the joint preparation tool 256through the lumen. The sleeve 266 may be secured to the jointpreparation tool 256 by any type of fastening mechanism such as, forexample, corresponding threading on the sleeve 266 and a proximalportion 270 of the shaft 268 of the tool 256. The rasping head 284 maybe fixed to the shaft 268 of the joint preparation tool 256 or the head284 may be releasably coupled to the shaft 268.

Moving on to another embodiment of a joint preparation tool 256 attachedto an anchoring arm assembly 258, reference is made to FIG. 25. Thejoint preparation tool 256 is identical to the tool 256 of FIGS.24A-24B. The anchoring arm assembly 258 of the present embodiment issimilar to the assembly 258 in FIGS. 24A-24B, except that the assembly258 in the present embodiment includes a trio of guide collars 272. Eachguide collar 272 is configured to orient a tool (not shown) in aspecific trajectory T1, T2, T3 relative to the rasping head 284 of thejoint preparation tool 256. T1 may, for example, orient an anchoringtool, as described previously, to deliver an anchor element cranial tothe rasping head 284. T2 may, for example, orient an anchoring tool todeliver an anchor element distally, in-line with the rasping head 284.T3 may, for example, orient an anchoring tool to deliver an anchorelement caudal to the rasping head 284. T2 may alternatively orient ananchoring tool to deliver an anchor element in-line with and towards acentral portion of the rasping head 284. In such an orientation, therasping head may include an opening (not shown) on its planar surfacethat extends proximally from a distal edge of the rasping head 284 suchthat the rasping head 284 is pronged or fork-shaped. While the anchoringarm assembly 258 is described as coupling to an anchoring tool thatdelivers an anchoring element that may be a screw, the assembly 258 maycouple with other types of tools. For example, the guide collars 272 maycouple with a syringe barrel that delivers a bone paste or otherbiomaterial into the joint space to facilitate fusion of the boneysurfaces of the joint.

While the anchor arm assemblies 258 of the various embodiments aredescribed with reference to a joint preparation tool with a shaftattached with a handle at a proximal end of the tool, the anchor armassemblies 258 may be used with other embodiments of the jointpreparation tool. For example, the anchor arm assemblies 258 may becoupled with the joint preparation tool 50 with the slap hammer assembly54 as described previously.

In another aspect, for example as shown and described in U.S.Provisional Patent Application 61/860,185, the anchor arm assembly 258may be provided in the form of two or more linked structural elementsthereby providing an adjustable elongate shape. For example, anchor armassembly 258 may be telescoping and may include a first section endingin the first arm end and a second section ending in the second arm end;both sections may have matched circular arc shapes with a common center.

-   -   For example, FIG. 56A and FIG. 56B are side views of a        telescoping anchor arm assembly 258. Referring to FIG. 56A, the        anchor arm assembly 258 may include a first section 4102 ending        in a first arm end 3802 and a second section 4104 ending in a        second arm end 3804; both sections 4102 and 4104 may have        matched circular arc shapes with a common center 4110 as        illustrated in FIG. 56A. In an aspect, the second section 4104        may have a hollow cross-section with a central lumen (not        shown), and the first section 4102 may he shaped and dimensioned        to fit within the central lumen by sliding along the arc length        of the second section 4104, FIG. 56B illustrates the anchor arm        assembly 258 with a portion of the first section 4102 nested        within the central lumen of the second section 4104, resulting        in a shorter elongate shape. The second section 4104 includes        the second arm end 3804 as well as a sliding attachment fitting        4106 at an end of the second section 4104 opposite to the second        arm end 3804. The sliding attachment fitting 4106 may slide        along the first section 4102 to adjust the relative position of        the first arm end 3802 and second arm end 3804 as illustrated in        FIG. 56B. The elongate shape of the anchor arm assembly 258 and        the sliding attachment fitting 4106 may he locked into a fixed        position using a locking mechanism including, but not limited        to, a set screw 4108 as illustrated in FIG. 56A. Any other known        locking mechanism may be used to lock the adjustable anchor arm        assembly 258 into a locked position including, but not limited        to clamps, pegs, compression fittings, and any combination        thereof. In this aspect, the shorter elongate shape illustrated        in FIG. 56B may result in a change in the angle 4112 between the        anchor element 18 and/or anchoring tool 274 and the implant 12        and/or tooling head 260. The adjustability of the anchor arm        assembly 258 may further facilitate fine-tuning the entry paths        of the various components during formation of the implant        assembly 14, or delivery of the anchor element 18 relative to        the tooling head 260, to account for variability in patient        morphology and/or to avoid injury to vulnerable tissues        including, but not limited to, nerves and/or blood vessels.

In an aspect, the second section may have a hollow cross-section with acentral lumen, and the first section may be shaped and dimensioned tofit within the central lumen by sliding along the arc length of thesecond section. A portion of the first section may be nested within thecentral lumen of the second section, resulting in a shorter elongateshape. The second section includes the second arm end as well as asliding attachment fitting at an end of the second section opposite tothe second arm end. The sliding attachment fitting may slide along thefirst section to adjust the relative position of the first arm end andsecond arm end. The elongate shape of the anchor arm assembly 258 andthe sliding attachment fitting may be locked into a fixed position usinga locking mechanism including, but not limited to, a set screw. Anyother known locking mechanism may be used to lock the adjustable anchorarm assembly 258 into a locked position including, but not limited toclamps, pegs, compression fittings, and any combination thereof. In thisaspect, the shorter elongate shape may result in a change in the anglebetween the anchor and/or anchor guide and the implant body and/orimplant guide. The adjustability of the anchor arm assembly 258 mayfurther facilitate fine-tuning the entry paths of the various componentsduring placement of the one or more anchors to account for variabilityin patient morphology and/or to avoid injury to vulnerable tissuesincluding, but not limited to, nerves and/or blood vessels.

In other aspects, the anchor arm assembly 258 includes a straighthorizontal segment and a straight vertical segment. The vertical segmentincludes the second arm end as well as a sliding attachment fitting atan end of the vertical segment opposite to the second arm end. Thesliding attachment fitting may slide in a horizontal direction along thehorizontal segment to adjust the relative position of the first arm endand second arm end. The position of the sliding attachment fitting maybe locked into place using any known locking mechanism describedpreviously above including, but not limited to, a set screw.

In various other aspects, the anchor arm assembly 258 may be madeadjustable by the incorporation of any other adjustable elements knownin the art. Non-limiting examples of suitable adjustable elementsinclude: two or more hinged or jointed subsections of the anchor armassembly 258, two or more telescoping subsections of the anchor armassembly 258, one or more bendable subsections of the anchor armassembly 258 having limited deformability, and any combination thereof.In other additional aspects, different sizes of fixed-geometry anchorarm assembly 258 may be used to provide a suitable range of installationtool geometries to account for differences in patient morphologies,differences in orthopedic surgical procedures, and any other variablefactor governing the selection of an anchor arm assembly 258 geometry.

C. Joint Preparation Tool with Translating and Rotation InhibitingDistal Handle Assembly

Reference is now made to FIG. 26A, which is a side isometric view of ajoint preparation tool 800 having a proximal handle 802 and a distalhandle assembly 804 that is slideably attached to a shaft 806 of atooling head 808. The distal handle assembly 804 is configured totranslate on the shaft 806 along a set trajectory that inhibits rotationof the handle assembly 804 relative to the proximal handle 802 and shaft806. The tooling head 808 may be similar to the various embodimentspreviously described and the joint preparation tool 800 may beconfigured to couple with any of the tooling heads described herein. Inthis embodiment, there is a cutting element 812 at a distal end 810 ofthe tooling head 808. Referring to the distal handle assembly 804, itincludes a coupler member 816 that releasably secures to the shaft 806of the tooling head 808. Proximal to the coupler member 816 is a handle818 that is coupled to the coupler member 816 via an adjustable socketassembly 820.

With continuing reference to FIG. 26A, the joint preparation tool 800may be further configured to have an indicator 803 coupled to orintegral with a component (e.g., the proximal handle 802) of the jointpreparation tool 800. The indicator 803 may indicate a position ororientation of the cutting element 812 when the cutting element ispositioned out of view of the surgeon (e.g., in a joint space).Alternatively, an indicator 803 may be fixed to a portion of thepatient's skeleton to act as a reference during the course of theprocedure. The indicator 803 may be configured as a body visible to ahuman user during the course of employing the joint preparation tool 800or one of its components. Additionally, the body may be configured to bevisible to a user while using fluoroscopy or CT scan (e.g., the body maycomprise a material which is radiopaque) or be identifiable by an O-arm®Surgical Imaging System from Medtronic or similar device or aStealthStation® S7® surgical navigation system by Medtronic which hasboth optical and electromagnetic tracking options, or a StealthStationi7′™ also by Medtronic. The indicator 803 may be used as a referenceguide when directly viewed by the human user or when identified by acomputer, surgical robot or imaging system. According to an aspect, theindicator 803 may be a reference array and may include 3 or 4 ballssupported in a predetermined spaced apart arrangement and connected toone another by a frame. The frame may be coupled to a component of thetool 800 or may be separately coupled to a portion of the patient'sskeleton or may be coupled to a delivery tool 16 of a system 10.

In another aspect, the indicator 803 may indicate the position of thecutting element 812 supported by the tooling head 808 when the toolinghead 808 may be obscured from view by the patient's soft tissues, by thepositioning of the tooling head 808 within the joint, or by aspects ofthe operating environment which may otherwise obfuscate the arrangementor position of elements of the various components of the jointpreparation tool 800. For example, the indicators 803 may be elongatecylinders extending radially from a proximal handle 802 (or shaft of atooling head 806) longitudinal axis and projecting towards one or moreouter cutting blades. In an aspect, the indicators 803 (when coupled tothe tool 800) have a longitudinal axis which is parallel to a cuttingelement axis which is defined as being coincident with the tooling headaxis and also coincident with a point along a tip of an outer cuttingblade 856.

As such, the indicator 803 may permit a surgeon to align an outercutting blade with the bone of an ilium and a second outer cutting bladewith the bone of the sacrum. Alternatively or additionally, an indicator803 may permit a surgeon to align an outer cutting blade 856 to begenerally in-line with a plane of a sacroiliac joint.

As seen in FIG. 26B, which is a cross-sectional view of the couplermember 816 of the distal handle assembly 804 and the shaft 806 of thetooling head 808, the shaft 806 is hexagonal and includes six outersurfaces 840 that are configured to matingly slide within and againstmatching inner surfaces 814 of the coupler member 816. The innersurfaces 814 of the coupler member 816 are hexagonal and sized slightlylarger than the six outer surfaces 840 of the shaft 806 in order tofacilitate sliding of the distal handle assembly 804 relative to theshaft 806. As seen in the figure, the coupler member 816 includes twosections that are held together by fasteners (e.g., bolt, screw) 822. Inthis way, the coupler member 816 is releasably secured to the shaft 806via the fasteners 822. And, when the coupler member 816 is secured tothe shaft 806, the coupler member 816, along with the socket assembly820 and the handle 818, are in a fixed position relative to the toolinghead 808 and the proximal handle 802. That is, the distal handleassembly 804 may translate on the shaft 806 of the tooling head 808, butthe distal handle assembly 804 may not rotate relative to the shaft 806.

In one aspect, coupler member 816 may be caused to disengage matchinginner surfaces 814 from outer surfaces 840 of the shaft 806 such thatrotation between shaft 806 and coupler member 816 may be permitted. Forexample, coupler member 816 may be distally displaced relative to shaft806 such that surfaces 814 and 840 disengage and then coupler member 816may be rotated relative to shaft 806 to a different desired position andthen coupler member 816 may be proximally displaced relative to shaft806 such that inner surfaces 814 reengage the outer surfaces 840.

Reference is now made to FIG. 26C, which is an isometric front view ofthe joint preparation tool 800 with the distal handle assembly 804 in anexploded view. As seen in the figure, the socket assembly 820 isreleasably secured to the coupler member 816 via a fastener 824 that isfitted within a passageway 826 through a socket member 828 of the socketassembly 820. The fastener 824 may be threaded and may engage withcorresponding threads in the coupler member 816. The socket member 828is coupled to the handle at a proximal end 830 of the socket member 828and includes a socket opening 832 at a distal end 834 of the member 828.The socket opening 832 leads to the passageway 826 and includes asix-sided inner surface 836 that may be engaged with a matching male-endof a six-sided member 838 on the coupler member 816. As such, the socketmember 828 may engage with and be secured to the six-sided member 838 inone of six orientations such that the handle 818 extends at differingorientations relative to the shaft 806 of the tooling head 808 and theproximal handle 802. This adjustability may be useful for a surgeon toappropriately position the handle 818 for a particular surgicalprocedure.

The present embodiment of the joint preparation tool 800 with atranslating and rotation inhibiting distal handle assembly 804 may beuseful to prevent inadvertent rotating of the cutting element 812 out ofa desired cutting trajectory. For example, since the ilium is generallya harder bone than the sacrum, there may be a tendency for the cuttingelement 812 to deflect from being driven into the ilium by twisting intothe joint space where this is less resistance. Such twisting of thetooling head 808 may be damaging to the patient and may inaccuratelyprepare the joint surfaces for fusion.

In operation, the cutting element 812 at the distal end 810 of thetooling head 808 may be distally driven into a joint (e.g., sacroiliacjoint) while a surgeon controls the trajectory of delivery. Moreparticularly, a surgeon may grasp the handle 818 of the distal handleassembly 804 with one hand and the proximal handle 802 with the otherhand. At this initial stage, the joint preparation tool 800 may beoriented as shown in FIG. 26A, which depicts the distal handle assembly804 in a distal position. The surgeon may then urge the proximal handle802 distally while maintaining a stabilizing force on the distal handleassembly 804. As the cutting element 812 is urged into the joint, thedistal handle assembly 804 may displace proximally relative to the shaft806 of the tooling head 808 as the surgeon maintains the stabilizingforce on the assembly 804. At this stage of the procedure, the jointpreparation tool 800 may be oriented as shown in FIG. 26D, which depictsthe distal handle assembly 804 in a proximal position. In this way, thestabilizing force exerted on the distal handle assembly 804 ensures thatthe cutting element 812 is not caused to inadvertently rotate out ofalignment during the delivery of the head 808 into the joint space.

Additionally, the coupler member may house a brake shoe which in turnmay carry a brake block or pad. The brake shoe may be coupled to a brakecaliper. The brake caliper may be manipulated by a user acting upon alever which may be configured with an ergonomic lever handle and whichmay be coupled to the distal handle assembly 804. Such a braking systemmay resist longitudinal and rotational forces between shaft 806 andcoupler member 816.

Moving on, reference is made to FIG. 26E, which is an up-close side viewof the cutting element 812. As seen in the figure, the cutting element812 includes a central cutting blade or central guide 842 and a pair ofouter cutting blades 844. The cutting element 812 also includes a frontand back wall member 846 that extends between and couples the outercutting blades 844 with the central cutting blade 842. The front andback wall members 846 may include a distal beveled edge 848 extendingbetween the outer cutting blades 844.

Referring to FIG. 26F, which is a cross-sectional side view of thecutting element 812, it can be seen that the shaft 806 of the toolinghead 808 tapers into the central cutting blade 842. In between oppositesides of the central cutting blade 842 and the outer cutting blades 844are passageways 850 that extend from the distal beveled edge to aproximal edge 852 of the cutting element 812. In operation, as thecutting element 812 is distally advanced within a joint space articularcartilage and/or bone may be cut with the distal beveled edge 848 andthe central and outer cutting blades 842, 844 such that the severedbone/cartilage is caused to funnel through the passageway 850 to makeway for additional bone/cartilage to be cut.

Such a cutting element 812 may be oriented within the joint plane orperpendicular to the joint plane. When oriented perpendicular to thejoint plane, one of the outer cutting blades 844 may be positioned tocut the ilium and one of the outer cutting blades 844 may be positionedto cut the sacrum while the central cutting blade is positioned withinthe plane of the joint. Thus, as the tool 800 is distally advanced thecutting element 812 may make keel cuts into the sacrum and the ilium.The distal handle assembly 804, as discussed previously, may be usefulto provide a stabilizing force that ensure the cutting element 812 doesnot inadvertently twist or rotate given the differences hardness of thesacrum and ilium.

The cutting element 812 may be modified, as in FIG. 26G, to include anelongated central cutting blade 842. Such a cutting element 812 may beuseful when the cutting element is oriented perpendicular to the jointplane, as described previously, in that the elongated central cuttingblade 842 may urge the cutting element 812 to stay within the jointplane as opposed to easily cutting into one of the boney surfaces of thejoint. The tip 854 of the elongated central cutting blade 842 may beblunt to further urge the central cutting blade 842 to remain within thejoint plane.

As seen in FIG. 26G, sample dimensions of the cutting element 812 may beas follows. The outer cutting blades may extend a distance D4 from thedistal edge 848 to a distal tip 856 of about 0 mm to about 1.75 mm, fromabout 1.5 mm to about 2.5 mm, from about 2 mm to about 3.5 mm, fromabout 3 mm to about 4.75 mm, from about 4.25 mm to about 6 mm, fromabout 5 mm to about 6.75 mm, from about 5.5 mm to about 8 mm, from about7.5 mm to about 10 mm, from about 9 mm to about 11.5 mm, and from about11 mm to about 13 mm. In certain embodiments, the distance D4 may beabout 1 mm, 3 mm, or 5 mm. The elongated central portion 842 may extenda distance D5 from the distal edge 848 to the tip 854 of about 3 mm toabout 4.75 mm, from about 4.25 mm to about 6 mm, from about 5 mm toabout 6.75 mm, from about 5.5 mm to about 8 mm, from about 7.5 mm toabout 10 mm, from about 9 mm to about 11.5 mm, from about 11 mm to about13 mm, and from about 12.5 mm to about 15 mm. In certain embodiments,the distance D5 may be about 5 mm, 6.5 mm, or 8 mm. The elongatedcentral portion 842 may extend a distance D6 beyond that of the distaltips 856 of the outer cutting blades by about 3 mm to about 15 mm. Incertain embodiments, the distance D6 may be about 5 mm, 6.5 mm, or 8 mm.A distance D7 between the distal and proximal edges 848, 852 may beabout 1.5 mm to about 2.25 mm, from about 2 mm to about 3.5 mm, fromabout 3 mm to about 4.75 mm, from about 4.25 mm to about 6 mm, fromabout 5 mm to about 6.75 mm, from about 5.5 mm to about 8 mm, from about7.5 mm to about 10 mm, from about 9 mm to about 11.5 mm, from about 11mm to about 13 mm, and may even range up to 40 mm-60 mm. In certainembodiments, the distance D7 may be 3.5 mm, 7.5 mm, 15 mm, 30 mm 40 mmor 45 mm. A distance D8 may be defined between one of the outer cuttingblades 844 and the elongated central cutting blade 842. D8 may be in arange of about 2.25 mm to about 2.75 mm, from about 2 mm to about 3.5mm, from about 3 mm to about 4.75 mm, from about 4.25 mm to about 6 mm,from about 5 mm to about 6.75 mm, from about 5.5 mm to about 8 mm, fromabout 7.5 mm to about 10 mm, from about 9 mm to about 11.5 mm, fromabout 11 mm to about 13 mm. In certain embodiments, the distance D8 maybe about 6 mm, 8 mm, or 10 mm.

While the cutting element is shown in FIGS. 26E-26G as including acertain configuration of cutting blades, other arrangements are possibleand contemplated herein. For example, a cutting element 812 may includeserrated cutting blades and may include additional or fewer cuttingblades than are depicted in the figures. In one aspect, there may befour passageways 850 arranged into two pairs. The first pair may bearranged such that the first and second passageways are positioned andaligned relative to one another similar to the configuration in FIGS.26F-26G such that a back wall member 846 of the first passageway isgenerally coplanar with a back wall member 846 of the second passagewayand forming a first plane. The second pair of passageways 850 may alsohave a relationship between each of the second pair passageways 850similar to the first and second passageways of the first pair ofpassageways such that a back wall member 846 of the first passageway ofthe second pair is generally coplanar with a back wall member 846 of thesecond passageway of the second pair and forming a second plane. Thesecond pair of passageways may be arranged relative to the first pair ofpassageways such that the first plane formed by the first pair of backwall members is generally perpendicular to the second plane formed bythe second pair of back walls.

D. Joint Preparation Tool with Trial Fit Implant and Cutting Tool withTranslating Cutting Element

The discussion of preparing the sacroiliac joint, among other joints,for implant delivery will now focus on additional tools that may be usedindependently from or in combination with the previously mentionedtools.

1. Trial Fit Assembly and Cutting Tool with Offset Shafts

To begin, reference is made to FIG. 27, which is an isometric side viewof a joint preparation tool assembly 300 that is configured to test-fitan implant size and make a transverse cut into either or both the sacrumand ilium to make way for a keel of an implant that is configured toextend into the bone. As seen in the figure, the joint preparation toolassembly 300 includes a trial tool assembly 302 and a cutting tool 304that is configured to translate relative to the trial tool assembly 302in order to make the transverse keel-cuts into the patient's bone.

The trial tool assembly 302 includes an implant trial 306 at a distalend 308 of the assembly 302. The implant trial 306 is a planar memberwith a tapered tip 310 that includes a width 312 that corresponds with awidth of an implant that may be subsequently delivered into a joint. Theimplant trial 306 may be removably coupled with a shaft 314 that extendsproximally. The shaft 314 is removably attached to a handle assembly 316at a proximal end 318 of the shaft 314. The handle assembly 316 includesa coupler 320 configured to removably attach to the shaft 314 of thetrial tool assembly 302. The coupler 320 is attached to a handle shaft410 that extends to a gripping handle 322.

As mentioned previously, the implant trial 306 is used to gauge the sizeof the joint space so that an implant size may be chosen that best fitsthe joint space. Thus, the system described herein may include implanttrials 306 of various sizes and configurations in order to gauge thesize of the joint space. In operation, a surgeon may begin a surgicalprocedure by test-fitting the smallest size of implant trial 306 intothe patient's joint to determine the fit. If the size of the implanttrial 306 is too small, then the surgeon may remove the implant trial306 and deliver a larger size implant trial 306 into the joint. Once anappropriate size of implant trial 306 is received within the joint, thesurgeon may use the cutting tool 304 to deliver transverse keel-cutsinto the boney surfaces in preparation for the implant delivery.

The cutting tool 304 is slidably coupled to the shaft 314 of the trialtool assembly 302 and configured to slide distal-proximal on the shaft314. The cutting tool 304 is slidably coupled to the shaft 314 via adistal and a proximal collar 324 that extend around the shaft 314 of thetrial tool assembly 302. The collars 324 are separated by a gap and areattached to a cutting tool shaft 326 that extends proximally. Thecutting tool shaft 326 includes a curved mid-portion 328 such that theshaft 326 angles away from the shaft 314 of the trial tool assembly 302.A proximal end 330 of the cutting tool shaft 326 includes an impactplate 332 that is configured for being hit with a hammer or similardevice to drive the cutting tool 304 distally. In this way, the surgeonmay securely hold the handle 322 of the trial tool assembly 302 with onehand and strike the impact plate 332 with the other hand.

Reference is now made to FIG. 28, which is an isometric view of anopposite side of the joint preparation tool assembly 300. As seen in thefigure, a distal end 334 of the cutting tool 304 includes a cuttingelement 336 that extends within a guide 338 formed in a top surface 340to the tapered tip 310 of the implant trial 306 when the cutting element336 translates relative to the implant trial 306. A distal tip 344 ofthe cutting element extends to the tapered tip 310 of the implant trial306 when the shaft 326 of the cutting tool 304 abuts a proximal end 346of the implant trial 306. The cutting tool 304 is configured to maintainan orientation relative to the guide 338 when the cutting element 336 isproximally retracted or distally extended towards the guide 338 via achannel 342 formed in the shaft 314 of the trial tool assembly 302.

For a detailed discussion of the cutting tool 304, reference is made toFIGS. 29-30, which are isometric views of the cutting tool 304. As seenin FIG. 29, the cutting tool 304 includes a protrusion 348 on each innersurface 350 of the collars 324 that extend around the shaft 314 of thetrial tool assembly 302. The protrusion 348 is configured to fit withinthe channel 342 formed in the shaft 314 of the trial tool assembly 302such that the shaft 314 cannot rotate when the protrusion 348 is fittedwithin the channel 342. Reference is now made to FIG. 30, which is aclose-up view of the distal end 334 of the cutting tool 304. As seen inthis figure, the protrusion 348 is semi-hemispherical and extends alength of the collars 324. Other shapes for the protrusion 348 arepossible and contemplated herein.

Turning to the distal end 334 of the cutting tool 304 and stillreferring to FIG. 30, the cutting element 336 is a six-sided, box-typechisel with planar outer surfaces 360 that distally terminates in abeveled cutting edge 362 that forms a distal opening 364 that extends tolumen extending through the cutting element 336. While this embodimentof the cutting element 336 includes a six-sided, box-type chisel, otherarrangements and designs of cutting tool elements 336 are contemplatedherein. For example, a rectangular, box-type chisel, knife blade, or sawmay be used without departing from the teachings of the disclosure.

Continuing with FIG. 30, the cutting element 336 further includes acutting element guide 352 that extends off of the cutting element 336and extends just proximally from the distal tip 334 of the cuttingelement 336 to a proximal end 354 of the cutting element 336. Thecutting element guide 352 includes a rounded head 356 and a neck 358that is thinner than a widest part of the head 356. Alternatively,cutting element guide 352 and guide channel 366 may have complementarydovetail or flaring tenon and mortise configurations. As seen in FIG.31, which is an isometric view of the cutting element 336 and implanttrial 306 with a cross-section at the proximal end 354 of the cuttingelement 336, the cutting element guide 352 is received within a guidechannel 366 that is a corresponding shape to that of the cutting elementguide 352. In particular, the guide channel 366 includes a neck region368 and a head region 370 that are only slightly larger than thecorresponding neck 358 and head 356 of the cutting element guide 352.The guide channel 366 extends from a proximal surface 372 to a distalsurface 374 of the implant trial 306. In this way, as the cutting tool304 and, more particularly, the cutting element 336 are translateddistally, the cutting element guide 352 is received within the guidechannel 366, which ensures that the cutting element 336 remains withinthe guide 338 on the top surface 340 of the implant trial 306 during acutting operation. Stated differently, the guide channel 366 preventsrotation and other errant movement of the cutting element 336 during acutting operation such that the cutting element 336 remains reliablywithin the guide 338 to perform repeatable and accurate cuts into thepatient's bone.

Still referring to FIG. 31 and also extending through the implant trial306 from the proximal surface 372 to a distal surface 374 is a bore 376that is configured receive a guidewire or similar device to guide theimplant trial 306 into a joint space, for example. As best seen in FIGS.32-33, which are respective front and back views of the implant trial306, both the bore 376 and the guide channel 366 extend through theimplant trial 306 parallel to a longitudinal axis of the implant trial306. While shown in the figures as generally linear, the longitudinalaxis of the implant trial 306 may be curved and may further include anarcuate portion with a radius between from about 3 cm and about 6 cm andmay be about 2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm, 4.5 cm, 5 cm, 5.5 cm, 6cm, 6.5 cm and 7 cm. In one aspect, while shown in the figures asgenerally linear, the guide channel 366 may be curved and may furtherinclude an arcuate portion with a radius that matches the curved implanttrial 306. The radius of the arcuate portion of the guide channel 366may be between from about 3 cm and about 6 cm and may be about 2 cm, 2.5cm, 3 cm, 3.5 cm, 4 cm, 4.5 cm, 5 cm, 5.5 cm, 6 cm, 6.5 cm and 7 cm. Inanother aspect, while shown in the figures as generally linear, theimplant trial 306 may be curved and may further include an arcuateportion with a radius between from about 3 cm and about 6 cm and may beabout 2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm, 4.5 cm, 5 cm, 5.5 cm, 6 cm, 6.5cm and 7 cm. In yet another aspect, the implant trial 306 and the guidechannel 366 may both include a matching radius.

Still referring to FIGS. 32-33, while the guide 338 is centered betweenopposite side surfaces 378 of the implant trial 306, the bore 376 andthe head region 370 of the guide channel 366 are offset from a centerpoint between the opposite side surfaces 378. As seen in the figures,the guide 338 is an extrusion with a bottom surface 380 that isgenerally perpendicular to a pair of side surfaces 382. The bottomsurface 380 adjoins one of the side surfaces 382 to form a perpendicularangle between the two surfaces while the opposite pair of surfaces aretransected by the guide channel 366 extending about one hundred andthirty-five degrees from each of the bottom surface 380 and the sidesurface 382.

Reference is now made to FIG. 33 and the proximal end 346 of the implanttrial 306. As seen in the figure, the channel 342 in the shaft 314 ofthe trial tool assembly 302 mirrors a portion of the circumference ofthe bore 376 extending through the implant trial 306. In this way, thetrial tool assembly 302 may be delivered into a sacroiliac joint, orother joint, of a patient by way of a guidewire (not shown) beingreceived through the bore 376 of the implant trial 306 which waspreviously delivered into the joint. The channel 342 in the shaft 314provides a passageway for the guidewire when the trial tool assembly 302is advanced into the joint. Subsequently, when it is appropriate to usethe cutting tool 304 with the trial tool assembly 302, the channel 342provides the function of guiding the cutting tool 304 in an appropriateorientation by aligning the protrusion 348 within the collars 324 of thecutting tool 304 within the channel 342 of the shaft 314 of the trialtool assembly 302.

As seen in FIGS. 43E and 43F, the implant trial 306 may have a lockingmeans which reversibly secures the trial 306 within the joint duringcertain steps in the procedure. For example, the proximal surface 372 ofthe implant trial 306 may have at least one passageway 307 whichcommunicates with either a top of bottom surface 340 which is configuredto receive an anchoring member 305 which may be proximally acted upon toreversibly transition from a recessed condition to a deployed condition.The recessed condition, as seen in FIG. 43E, is such that the anchoringmember 305 is recessed within the passageway 307 or simply not extendingbeyond the top surface 340 and thereby not engaging a bone defining thejoint and thereby not preventing movement of the implant trial 306relative to the joint. The deployed condition, as seen in FIG. 43F, issuch that the anchoring member 305 projects out of the passageway 307from the top surface 340 thereby engaging a bone of the joint which mayprevent or at least limit the movement of the implant trial 306 duringthe course of the procedure. The anchoring member 305 may be a spike,pin, dart, screw or other suitable locking or restraining member.

As further seen in FIG. 34, which is a front view of the trial toolassembly 302, an outer surface 384 of the shaft 314 of the trial toolassembly 302 lies flush with one of the outer surfaces 378 of theimplant trial 306. As discussed previously, the proximal end 318 of theshaft 314 in configured to engage with a handle assembly 316. Tofacilitate the coupling of the shaft 314 and the handle assembly 316,the shaft 314 includes a notch or indent 386 within the outer surface384 of the shaft 314. Proximally from the notch 386 is a stop feature388 that defines a partial planar resection or flattening 390 of theouter surface 378 of the shaft 314.

For a discussion of the engagement of the handle assembly 316 with theshaft 314, reference is made to FIG. 35, which is a cross-sectionalisometric view of the handle assembly 316 and the proximal end 318 ofthe shaft 314. As seen in the figure, the coupler 320 includes acylindrical sidewall 404 and a flat impacting end 412 at a proximal end414 of the coupler 320. Opposite the proximal end 414, a distal end 394of the coupler 320 includes an opening 392 that is configured to receivethe proximal end 318 of the shaft 314. The opening 392 includes apassageway that extend partially through the coupler 320 and includes aproximal inner surface 396 that is sized slightly larger than theproximal end 318 of the shaft 314. The inner surface 396 includes aplanar inner surface portion 398 that matches the planar surface 390 ofthe shaft 314 such that when the shaft 314 is inserted into the opening392, the planar surface 390 of the shaft 314 lies flush and opposed withthe planar inner surface 398 of the opening 392 in a single orientation.When the shaft 314 is fully inserted into the opening 392, the stopfeature 388 abuts a corresponding feature 400 on the inner surface 396of the opening 392, which prevents further extension of the shaft 314into the opening 392. Also, when the stop feature 388 abuts thecorresponding feature 400, the notch 386 is aligned with a lock feature402 that extends through a bore in the cylindrical sidewall 404 of thecoupler 320. The lock feature 402 includes a tubular member that isconfigured to extend through the sidewall 404 and into the notch 386while still being partially positioned in the sidewall 404 in order tolock the shaft 314 in place relative to the coupler 320. The lockfeature 402 may be engaged and disengaged from within the notch 386 byactivation of a set screw 406 or similar mechanism. In this embodiment,the set screw 406 is maintained within the sidewall 404 of the couplerby a retainer 408 that inhibits movement of the set screw 406 from fullretraction outside of the sidewall 404. The function of the lock feature402 and the set screw 406 may be accomplished with many differentmechanisms and methods. For example, the set screw 406 may besubstituted for a mechanical switch that forces the lock feature 402into the notch 386 when the switch is engaged. This and other suchmechanisms are possible and contemplated by this disclosure.

Turning now to FIGS. 36A-36B, reference is made to another embodiment ofthe cutting tool 304. As seen in FIG. 36A, the cutting tool 304 includea similar shaft 326 with a curved mid-portion 328, distal and proximalcollars 324 for receiving a shaft of a trial tool assembly, and animpact plate 332 at a proximal end 330 of the cutting tool 304 asdescribed with reference to the previous embodiment of the jointpreparation tool assembly 300. The present embodiment differs, however,from the previously described embodiment of the joint preparation toolassembly 300 in that it includes a saw-blade type cutting element 416 ata distal end 334 of the cutting tool 304. Referring to FIG. 36B, whichis a close-up isometric view of the distal end 334 of the cutting tool304, the cutting element 416 extends from a planar distal surface 418 ofthe tool 304 and includes opposite side surfaces 420, a bottom surface422, and a top surface 424 that includes a series of teeth 426 arrangedin a saw tooth shape that is configured to cut during a distal extensionof the cutting tool 304. The series of teeth 426 extend generallyperpendicularly from a top surface 430 of the shaft 326. At a distal end334 of the cutting tool 304, the top surface 424 of the cutting element416 tapers towards the bottom surface 422 to form a rounded, tapereddistal tip 428.

In certain embodiments of the cutting tool 304, the cutting element 416may include a width W416 between the opposite side surfaces within arange of about 1 mm to about 1.25 mm, from about 1 mm to about 1.75 mm,from about 1.5 mm to about 2.25 mm, from about 2 mm to about 2.75 mm,from about 2.5 mm to about 3 mm, from about 2.75 mm to about 4.25 mm,from about 4 mm to about 5 mm, from about 4.75 mm to about 6 mm, fromabout 5.75 mm to about 7 mm, and from about 6.5 mm to about 7.5 mm. Incertain instances, the width W416 may be about 1.5 mm, 1.75 mm, 2 mm,2.75 mm, 3 mm or 3.5 mm X. In certain embodiments, the cutting element416 may include a length L416 from the planar distal surface 418 to thetapered distal tip 428 within a range of about 10 mm to about 15 mm,from about 13 mm to about 20 mm, from about 17.5 mm to about 30 mm, fromabout 25 mm to about 37.5 mm, from about 35 mm to about 40 mm, fromabout 37 mm to about 50 mm. In certain instances, the length L416 may beabout 27 mm, 30 mm, 37 mm, or 40 mm. In certain embodiments, the cuttingelement may include a height H416 from the bottom surface 422 to theseries of teeth 426 within a range of about 2.25 mm to about 2.65 mm,from about 2.5 mm to about 3 mm, from about 2.75 mm to about 4.25 mm,from about 4 mm to about 5 mm, from about 4.75 mm to about 6 mm, fromabout 5.75 mm to about 7 mm, from about 6.5 mm to about 7.5 mm, fromabout 7 mm to about 8.75 mm, from about 8.5 mm to about 9.75 mm and fromabout 9.5 mm to about 11.25 mm. In certain instances, the height H416may be about 3.25 mm, 4 mm, 4.5 mm, 5 mm or 5.25 mm.

The cutting tool 304 of FIGS. 36A-36B is configured to be used with thetrial tool assembly 302 as described previously. The cutting tool 304 inFIGS. 36A-36B may be useful, for example, in making a keel-cut intoeither the sacrum or the ilium after the implant trial of the trial toolassembly is delivered non-transversely into the sacroiliac joint. Sincethe cutting element 416 extends generally perpendicular from the shaft326 of the cutting tool 304, when the implant trial is positionednon-transversely within the sacroiliac joint, the series of teeth 426will be oriented generally perpendicularly to the sacrum/ilium such thata distal extension of the cutting tool 304 will provide a cut into thebone that may match a keel or wing member of an implant to besubsequently implanted into the joint space.

Reference is now made to FIGS. 36C-36E, which depict an alternativeimplant trial 306 and cutting element 416. As seen in FIG. 36C, thecutting element 416 may include interconnected teeth 764 forming a chainthat are configured to rotate around a portion of the implant trial 306.The interconnected teeth 764 may be segmented into individual teeth 764and each segmented tooth 764 may be in-line and linked with one anothervia rivets 766 or similar mechanisms. The interconnected teeth 764 maybe configured similar to a tooth on a chainsaw and dimensioned as hereindescribed, however, the overall length of each tooth 764 will be afraction of the total length L416 of the cutting element segmentassembly. For example, if the assembly comprises three teeth 764, thanthe length of each tooth will be approximately one third of the overalllength L416 of the cutting element segment assembly. In an aspect, anassembly comprises fifteen teeth 764 with each tooth approximately 2 mmin length. In one aspect, the teeth 764 are configured similar tochipper teeth or an OREGON no. 10 chipper chain, one of many STIHL sawchains or even a full-chisel chain. In other aspects, the teeth 764 maybe configured as other linked-chains known in the art.

The interconnected teeth 764 may be configured to rotate through aportion of a length of the implant trial 306 such that a portion of theteeth 764 extend above a top surface 768 of the implant trial 306. Thus,in operation and during rotation, the interconnected teeth 764 areconfigured to deliver a cut (e.g., keel-cut) into a joint bone when theimplant trial 306 is positioned within a joint space. The interconnectedteeth 764 opposite the top surface 768, may extend outward from a bottomsurface of the implant trial 306 such that rotation of theinterconnected teeth 764 delivers simultaneous cuts to opposing bones ina joint space. Or, alternatively, the teeth 764 opposite the teeth 764on the top surface 768 may remain housed within a passageway within thebody of the implant trial 306 such that the teeth 764 only contact ajoint bone that opposes the top surface 768.

Referring to FIG. 36D, which is a top view of an implant trial 306 thatis suitable for use with the cutting element 416 described previously,the implant trial 306 may include a first guide or channel 338 formed inthe top surface 768 and a second guide or channel (not shown) formed inthe bottom surface of the implant trial 306, which is opposite the topsurface 768 and not shown in FIG. 36D. And, at a distal end 774 of theimplant trial 306, there may be a passageway 770 communicating betweenimplant trial top and bottom surfaces 768. The passageway 770 may beconfigured and dimensioned to receive the interconnected teeth 764 asthey run distal-proximal along the first and second guides 338 throughthe passageway 770. Such a configuration of the interconnected teeth 764with the implant trial 306 having a passageway 770 at the distal end 774may permit use of a rotating chain of teeth while protecting a patient'stissue that is distal to the distal end 774 of the implant trial 306.

Referring now to FIG. 36E, which is an isometric view of an arcuateimplant trial 306 coupled with a shaft 780, the teeth 764 may be linkedtogether such that they pivot relative to one another with a pivot axiswhich is generally perpendicular to the length of the trial guide 338and perpendicular to the top surface 768 of the implant trial 306. Sucha configuration would permit a saw chain of interconnected teeth 764 totravel an arcuate path via an arcuate trial guide path 772 formed on agenerally planar implant trial top surface 768 where the opposite sidesurfaces 776 of implant trial 306 are curved and have a radius ofapproximately 2 cm to about 8 cm. In this arrangement a cutting tip ofthe interconnected teeth 764 remains oriented perpendicular to the topsurface 768 of the implant trial 306; however, the orientation of thepivot 766 is altered from the previous embodiment. As describedpreviously, the interconnected teeth 764 may travel along the arcuatetrial guide path 772 until the teeth 764 enter the passageway 770 at thedistal end 774 of the implant trial 306. The teeth 764 may then exit thepassageway 770 and travel proximally on the arcuate trial guide path 772formed on the bottom surface 778 of the implant trial 306. In thisarrangement, the interconnected teeth 746 may include an additionalpivot 766 oriented generally perpendicular to the previously describedpivot 766 such that the additional pivot 766 enables movement of thechain of interconnected teeth 764 to travel through the passageway 770.Alternatively, the implant trial 306 may not include a passageway 770and the teeth 764 may simply translate distally-proximally within theguide paths 772.

Other cutting elements 416 are possible and contemplated herein. Forexample, the cutting element 416 may include a serrated or smooth knifeblade. And, the joint preparation tool assembly 300 may include a seriesof cutting tools 304, each cutting tool 304 with progressively larger(e.g., wider) blades that may or may not be used in succession to makelarger and larger cuts until a desired cut size is made for subsequentimplant delivery.

2. Trial Fit Assembly and Cutting Tool with Coaxially Aligned Shafts

Turning now to another embodiment of a joint preparation tool assembly450, reference is made to FIG. 37. As seen in the figure, the jointpreparation tool assembly 450 includes a trial tool assembly 452 and acutting tool 454 that translates on a shaft 456 of the trial toolassembly 452. The cutting tool 454 includes a tubular shaft 458 havingan outer surface 460, an inner surface 462, and a hollow interior space464. The tubular shaft 458 also includes a series of apertures 466extending from the outer surface 460 to the inner surface 462 of theshaft 458. The apertures 466 provide for easier and improved steamcleaning compared with a tubular shaft without apertures. The apertures466 also reduce weight of the assembly 450, among other benefits. Thetubular shaft 458 or, more particularly, the hollow interior space 464is configured to receive the shaft 456 of the trial tool assembly 452such that the shafts 456, 458 are coaxially aligned. At a proximal end468, the cutting tool 454 includes a handle 470. At a distal end 472,the cutting tool 454 includes a cutting element 474, which, in thisembodiment, is a box-type chisel as described previously.

Regarding the trial tool assembly 452, the assembly includes an implanttrial 476 at a distal end 478 of the assembly. As seen in FIG. 38, whichis an isometric view of the cutting tool 454 and the trial tool assembly452 in an uncoupled state, it can be seen that the trial tool assembly452 is similar to and may include the same or different features of thejoint preparation tool assembly 300 discussed previously in FIGS. 27-35.That is, the trial tool assembly 452 includes the implant trial 476 atthe distal end 478 of the assembly, a guide 480 on a top surface 482 ofthe implant trial 476, and a guide channel 484 that is configured toguide the cutting element 474 during translation of the cutting element474 within the guide 480 of the implant trial 476.

To couple the trial tool assembly 452 and the cutting tool 454, theshaft 456 of the trial tool assembly 452 is received through a pair ofcollars 486 on the cutting tool and is translated proximally such thatthe shaft 456 is received within the tubular shaft 458 of the cuttingtool 454. As seen in FIG. 38, the cutting tool 454 includes a protrusion488 within each of the collars 486 that fit within a correspondingchannel 490 formed within an outer surface 492 of the shaft 456 of thetrial tool assembly 452. The interaction of the protrusion 488 and thecorresponding channel 490 ensures that the trial tool assembly 452maintains its orientation relative to the cutting tool 454 duringdistal-proximal movement. As the trial tool assembly 452 is proximallyretracted within the tubular shaft 458 of the cutting tool 454, acutting guide element 494 of the cutting tool 454 will engage with andbe received within the guide 480 of the implant trial 476. Theinteraction of the cutting guide element 494 and the guide 480 and guidechannel 484 further ensures that the orientation of the cutting tool 454and the trial tool assembly 452 will be maintained during a cuttingstroke of the cutting tool 454 during a surgical procedure.

3. Trial Fit Assembly, Cutting Tool, and Trial Impact Rod with CoaxiallyAligned Shafts

Turning now to another embodiment of a joint preparation tool assembly500, reference is made to FIG. 39, which depicts the individualcomponents of the assembly 500 in an uncoupled state. As seen in thefigure, the joint preparation tool assembly 500 includes a trial toolassembly 502, a trial impact rod assembly 504, a handle assembly 506,and a cutting tool 508.

In one aspect, the trial impact rod assembly 504 is configured to beused in conjunction with the trial tool assembly 502 to providestability during delivery of a distal end 510 of the trial tool assembly502 into a joint of a patient. In particular, slidable coupling of thetrial impact rod assembly 504 and the trial tool assembly 502 addsstability and rigidity to the assembly 500 by reducing potentialbending, among other movements, of the trial tool assembly 502 shaft 512during a striking of the handle assembly 506.

In another aspect, the cutting tool 508 is configured to be used inconjunction with the trial tool assembly 502 to deliver a transversekeel-cut into a bone of a joint. For example, the distal end 510 of thetrial tool assembly 502 may be delivered non-transversely into asacroiliac joint of a patient with stabilizing support from the trialimpact rod assembly 504 and, then, once the trial impact rod assembly504 is decoupled from the trial tool assembly 502, the cutting tool 508may be may be slidably coupled with the trial tool assembly 502 and usedto transversely cut into either or both of the sacrum and the ilium tomake way for subsequent delivery of an implant having transverselyextending members that match the cuts made into the sacrum/ilium. Ineach of the examples described above, the handle assembly 506 may becoupled to a proximal end of the trial impact rod 504 or the cuttingtool 508 and a device (e.g., hammer, mallet) may be used to strike thehandle assembly 506 in order to distally drive the assembly 500.

To begin the discussion of the components of the joint preparation toolassembly 500, reference is made to the trial tool assembly 502 in FIG.39. As seen in the figure, the trial tool assembly 502 includes animplant trial 514 at the distal end 510 of the assembly 502. The implanttrial 514 is a planar member with a top surface 516, a bottom surface518 that is opposite the top surface 516, and opposite side surfaces520. The top surface 516 includes a channel 522 that guides a cuttingelement 524 of the cutting tool 508. The channel 522 extends from atapered distal tip 526 to a proximal end 528 of the implant trial 514and is coaxial with a shaft channel 530 that extends the length of theshaft 512 from the proximal end 528 of the implant trial 514 to aproximal end 532 of the shaft 512. In this way, the cutting element 524of the cutting tool 508 may be guided along the shaft channel 530 whilethe cutting element 524 is proximal of the implant trial 514. And, whenthe cutting element 524 is distally advanced it will also be guided bythe channel 522 in the top surface 516 of the implant trial 514. Shaftchannel 530 may simply be a planar surface along shaft 512 and alignedwith a corresponding planar surface of channel 522.

As seen in FIG. 39, the shaft 512 of the trial tool assembly 502 iscentrally positioned on a proximal surface 534 of the implant trial 514.On the proximal surface 534 of the implant trial 514 and on either sideof the shaft 514 are bores 536 that extend distally through a portion ofthe implant trial 514. The bores 536 are configured to receive acorresponding pair of stud members 538 on a distal end 540 of the trialimpact rod assembly 504. When the stud members 538 are received withinthe bores 536, the implant trial 514 is correctly aligned with thedistal end 540 of the trial impact rod 504. Alternatively, the bores maybe studs and the studs bores.

Now the discussion will focus on the trial impact rod assembly 504 ofFIG. 39. As seen in the figure, the trial impact rod assembly 504includes a tubular shaft 542 that couples or transitions to an implanttrial extension member 544 at the distal end of the trial impact rodassembly 504. The implant trial extension member 544 is a planar memberthat includes the stud members 538 on a planar distal surface 546 of themember 544. The shaft 512 of the trial tool assembly 502 is configuredto be received within an interior space 548 in the tubular shaft 542 andthe stud members 538 are configured to be received within the bores 536on the proximal surface 534 of the implant trial 514. In thisarrangement, when the shaft 512 of the trial tool assembly 502 is fullyreceived within the tubular shaft 542 of the trial impact rod assembly504, the proximal surface 534 of the implant trial 514 and the distalsurface 546 of the implant trial extension member 544 abut each other.The implant trial extension member 544 acts as a natural extension ofthe implant trial 514 such that when the implant trial 514 is deliveredinto a patient's joint, the distal end 540 of the trial impact rodassembly 504 may also be delivered into the joint space withoutstoppage. Stated differently, the implant trial extension member 544includes top and bottom surfaces 550, 552 and opposite side surfaces 554that align with and provide a smooth transition between (i.e., coplanar)the top, bottom, and opposite side surfaces 516, 518, 520 of the implanttrial 514. Alternatively, implant trial extension member 544 may have atransition which intentionally interferes with a bone of the joint inorder to act as a stop. The stop feature may be adjustable or fixed.

At a mid-portion 570 of the trial impact rod assembly 504, a screw-lock572 is rotatably coupled to the tubular shaft 542 and configured tofrictionally lock or support the shaft 512 of the trial tool assembly502 when the shaft 512 is received within the tubular shaft 542 of thetrial impact rod assembly 504. The screw-lock 572 may function to lockthe shaft 512 in place in many ways. For example, the screw-lock 572 mayrotationally advance on a pair of threaded push-locks (not shown) thatextend through the tubular shaft 542 such that when the screw-lock 572is rotationally engaged over the push-locks, the push-locks are causedto extend further through the tubular shaft 542 and into contact withthe shaft 512 of the trial tool assembly 502. Such contact with theshaft 512 of the trial tool assembly 502 may cause sufficient frictionto securely support the positioning of the shaft 512 within the tubularshaft 542.

Also as seen in FIG. 39, a proximal end 556 the trial impact rodassembly 504 includes a handle engagement mechanism 558 that includes apair of block-like members 560 with four generally perpendicularsidewalls 562 separated by mid-section member 564 with four slightlyconcave sidewalls 566 that are generally coplanar with a pair ofcorresponding sidewall 562 of the pair of block-like members 560. Thehandle engagement mechanism 558 is configured to be received and securedwithin a distal opening 568 in the handle assembly 506. The distalopening 568 extends to a cavity 586 for housing and securing of thehandle engagement mechanism 558.

Moving on, reference is made to the cutting tool 508 in FIG. 39. As seenin the figure, the tool 508 includes a shaft 590 that is coupled to thecutting element 524 at a distal end 592 of the cutting tool 508. Thecutting element 524 is a planar member with generally parallel oppositesides and a top surface 598 that extends outward and distally from anouter surface 594 of the shaft 590. The cutting element 524 includes aseries of teeth 596 on the top surface 598 of the cutting element 524.The cutting element in this embodiment is similar to as described inreference to FIGS. 36A-36B. Alternatively, the cutting element 524 maybe as described in other portions of this disclosure. For example, thecutting element 524 may include a box chisel, serrated knife blade, etc.

The shaft 590 of the cutting tool 508 is tubular and includes aninternal passageway 600 that is configured to receive the shaft 512 ofthe trial tool assembly 502. When the shaft 512 is fully received withinthe tubular shaft 590 of the cutting tool 508, the cutting element 524or, more particularly, a bottom surface 602 and a portion of oppositesidewall surfaces 604 of the cutting element 524 are guided by andpositioned within the channel 522 on the top surface 516 of the implanttrial 514. The cutting tool 508 may include a protrusion (not shown) onthe internal passageway 600 of the shaft 590 that is configured toengage with and be guided by the shaft channel 530 of the trial toolassembly 502. When the implant trial 514 is delivered into a joint of apatient, a distal stroke of the cutting element 524 relative to theimplant trial 514 is configured to make a keel-cut perpendicular to aplane defined by the joint for the subsequent delivery of an implanthaving matching keels or wing members.

Referring to a proximal end 606 of the cutting tool 508, the shaft 590is coupled or transitions to a handle engagement mechanism 608 that issimilar to the mechanisms 558 on the trial impact rod assembly 504. Thehandle engagement mechanism 608 includes a pair of block-like members610 with four generally perpendicular sidewalls 612 separated by asmaller mid-section member 614 with four slightly concave sidewalls 616that are generally coplanar with a pair of corresponding sidewall 612 ofthe pair of block-like members 610. The handle engagement mechanism 608is configured to be received and secured within the distal opening 568in the handle assembly 506. As stated previously, the distal opening 568extends to the cavity 586 for housing and securing of the handleengagement mechanism 608.

Referring to the handle assembly 506 in FIG. 39, the assembly 506includes a coupler 574 that is configured to receive and support thehandle engagement mechanisms 558, 608 on the trial impact rod assembly504 and the cutting tool 508 within the distal opening 568. The coupler574 includes a cylindrical sidewall 576 and a flat impact plate 578 thatis opposite the distal opening 568 and configured to be struck with ahammer, mallet, or similar device in order to distally drive the jointpreparation tool assembly 500 within a joint. Extending from andattached to the cylindrical sidewall 576 is a shaft 580 that furtherextends to a handle 582.

Still referring to the handle assembly 506 of FIG. 39, the coupler 574includes a camming mechanism 584 that is configured to securely supportthe trial impact rod assembly 504 or the cutting tool 508 when theproximal end of the assembly 504 or tool 508 is positioned within thecavity 586 of the handle assembly 506. The camming mechanism 584includes a handle 588 that transitions to a camming head having acam-shaped surface. The camming head is coupled to the coupler 574 by anaxle that extends through an aperture in the cylindrical sidewall 576and is configured such that when the camming head is rotated about theaxle, the cam-shaped surface contacts and locks against one of theconcave sidewalls 566, 616 that is positioned adjacent the aperture.When the camming head is rotated in an opposite direction, thecam-shaped surface disengages with the concave sidewalls 566, 616 suchthat the trial impact rod assembly 504 or the cutting tool 508 may beremoved from the cavity 586 in the coupler 574.

Reference is now made to FIGS. 40A-C, which are isometric views of thetrial tool assembly 502 and the trial impact rod assembly 504 couplingtogether. As seen in FIG. 40A, the tubular shaft 542 of the trial impactrod assembly 504 is coaxially aligned with the shaft 512 of the trialtool assembly 502 such that the shaft 512 may be received within theinterior space 548 of the tubular shaft 542. In this arrangement, asseen in FIG. 40B, which is a close-up view of the engagement of theimplant trial 514 with the distal end 540 of the trial impact rodassembly 504, the stud members 538 on the trial impact rod 504 arealigned and configured to be received within the bores 536 on theproximal surface 534 of the implant trial 514. As seen in FIG. 40C, oncethe trial tool assembly 502 is received within the trial impact rodassembly 504, the screw-lock 572 may be rotationally engaged tofrictionally support the shaft 512 of the trial tool assembly 502,which, in turn, securely supports the positioning of the trial toolassembly 502 relative to the trial impact rod assembly 504.

Reference is now made to FIG. 41, which is an isometric view of thetrial impact rod assembly 504 and the trial tool assembly 502 coupledtogether with the handle assembly 506 in close proximity. As seen in thefigure, the handle engagement mechanism 558 is positioned to be receivedwithin the distal opening 568 in the handle assembly 506. Also, aguidewire 618 is positioned to be received within the channel 522 on thetop surface 516 of the implant trial 514. After being received withinthe channel 522, the guidewire 618 may be further received within andguided by the shaft channel 530 in the shaft 512 of the trial toolassembly 502. In this way, the guidewire 618 may be delivered into ajoint of a patient and the assembly 500 including the impact rodassembly 504 and the trial tool assembly 502 may be delivered into thejoint via the guidewire 618 being received within the channel 522. Oncethe handle assembly 506 is coupled to the trial impact rod assembly 504,a mallet may be used to impact the handle assembly 506 in order tosufficiently drive the distal end 510 of the trial tool assembly 502into the joint. And, once the implant trial 514 is sufficientlydelivered within the joint space, the handle assembly 506 may bedecoupled with the trial impact rod assembly 504. Next, the screw-lock572 on the trial impact rod assembly 504 may be loosened so that theassembly 504 may be slidably removed from the trial tool assembly 502,which remains within the joint space. At this point, the guidewire 618may be removed. Alternatively, the guide wire may be removed at any timeduring the procedure.

Reference is now made to FIGS. 42A-42B, which are isometric views of thetrial tool assembly 502 and the cutting tool 508 coupling together. Asseen in FIG. 42A, the shaft 512 of the trial tool assembly 502 iscoaxially aligned with and configured to be received within the internalpassageway 600 of the shaft 590 of the cutting tool 508. The cuttingelement 524 is aligned with and guided by the channel 522 on the topsurface 516 of the shaft 512 as the cutting tool 508 is distallyadvanced relative to the trial tool assembly 502. That is, the bottomsurface 602 and a portion of the opposite sidewall surfaces 604 arefitted and guided within the channel 522 such that rotation of thecutting tool 508 relative to the trial tool assembly 502 is restricted.

As seen in FIG. 42B, once the trial tool assembly 502 is coupled withthe cutting tool 508, the handle assembly 506 may be coupled with thehandle engagement mechanism 608 on the cutting tool 508. The handleassembly 506 may be struck with a mallet in order to distally drive thecutting element 524 relative to the implant trial 514 in order to make akeel-cut transverse to the joint. The cutting tool 508 may be distallydriven relative to the implant trial 514 until a distal edge 620 of theshaft 590 abuts the proximal surface 534 of the implant trial 514. Atthis point, the distal end 592 of the cutting element 524 is positionedat the distal tip 526 of the implant trial 514.

Once the keel-cut has been made, the handle assembly 506 and the cuttingtool 508 may be decoupled from the trial tool assembly 502 (eithertogether or individually). Then, the trial tool assembly 502 may beremoved from the joint space for subsequent delivery of an implant thatmatches the space that was cleared by the implant trial 514 and thecutting tool 508.

While the joint preparation tool assembly 500 as described in theprevious figures includes an implant trial 514 with a single channel 522and a cutting tool 508 with a single cutting element 524, the assembly500 may include implant trials 514 and cutting tools 508 with multiplechannels 522 and cutting elements 524. For example, a certain jointpreparation tool assembly 500 may include an implant trial 514 withchannels 522 on a top and bottom surface 516, 518 and a cutting tool 508with cutting elements 524 on opposite sides of the shaft 590 such thatthe assembly 500 may deliver simultaneous, dual keel-cuts into a jointspace (e.g., into both sacrum and ilium). As another example, a certainjoint preparation tool assembly 500 may include an implant trial 514with a pair of channels 522 on both a top and a bottom surface 516, 518and a cutting tool 508 with a pair of cutting elements 524 on oppositesides of the shaft 590 in order to make quad keel-cuts into the bonesdefining the sacroiliac joint space to make way for an implant having anI-beam shape as described in U.S. patent application Ser. No.14/447,612, mentioned previously, and hereby incorporated by referencein its entirety. Other embodiments of the assembly 500 are contemplatedand within the scope of the present disclosure.

As further examples of alternative configurations of the implant trial514 and cutting element 524, reference is made to FIGS. 43A-43D, whichare respective front views of implant trials 514 with variousconfigurations of cutting elements 524 channels 522. As seen in FIG.43A, the channel 522 is formed by one of the side surfaces 520 thatextends from the proximal end 528 of the implant trial 514 to the distalend 510 of the trial tool assembly. The channel 522 includes a neckportion 622 and a bulb-end portion 624 that is wider than the neckportion 622. In this way, once the cutting element 524 is receivedwithin the channel 522, the cutting element 524 is restrained frommovement out of the channel 522 except by distal-proximal translation ofthe cutting element 524 relative to the implant trial 514.

Regarding the cutting element 524, it includes an implant trialengagement end 626 and a cutting end 628. The engagement end 626includes a neck member 630 that extends to a bulb-member 632 that isslidingly and matingly received within the channel 522 by distallytranslating the cutting element 524 such that the engagement end 626 ofthe cutting element 524 is engaged and fitted within the channel 522 atthe proximal end 528 of the implant trial 514. The channel 522 describedherein may include additional mechanisms to restrain the cutting element524 during distal-proximal translation. The description of a channel 522having a neck portion 622 and a bulb portion 624 is illustrative and notintended to be limiting.

Regarding the cutting end 628 of the cutting element 524, as seen inFIG. 43A, the cutting end 628 transitions generally ninety degrees fromthe implant trial engagement end 626 and extends generally parallel withthe side surface 520 of the implant trial 514. In particular, thecutting end 628 terminates in a cutting tip 634 that extends beyond thetop surface 516 of the implant trial 514. In this way, as the cuttingelement 524 is distally translated, the patient's bone (e.g., sacrum orilium) that abuts the top surface 516 of the implant 514 will be cut.

Referring to FIG. 43B, the cutting element 524 may be a T-shaped memberand include a pair of cutting tips 634 where one cutting tip extendsbeyond the top surface 516 and one cutting tip extends beyond the bottomsurface 518 of the implant trial 514. In this arrangement, the cuttingelement 524 may be used to deliver simultaneous cuts into opposing bonesdefining a joint (e.g., sacrum and ilium). And, referring to FIG. 43C,the cutting element 524 may include two T-shaped members wherein oneT-shaped member is on each side surface 520 of the implant trial. Inthis arrangement, the cutting element 524 may be used to deliverdual-keel cuts into each of the sacrum and ilium. Such cuts may beuseful for delivery of an implant having a pair of keels that areconfigured to extend into the sacrum and ilium.

And, while this discussion has focused on cutting elements 524 withcutting tips 634, other cutting devices that include a similar implanttrial engagement end may be used with the implant trial 514 of thepresent discussion. For example and as seen in FIG. 43D, the cuttingelement 524 includes a T-shaped member with a cutting tip 634 aspreviously described on one side surface 520 and a box-chisel 636 on theopposite side surface 520. The box-chisel 636 may be useful, forexample, to clear the plane of the joint while the T-shaped member withthe cutting tips 634 may be useful for cutting into the sacrum and iliumto prepare for the subsequent delivery of a matching implant. Similarly,instead of the box chisel 636 as shown and positioned in FIG. 43D, adrill guide collar 710 may be positioned and arranged in place of thebox chisel; however, the collar would be positioned adjacent theproximal surface of the implant trial as in FIG. 44 by aligned with oneor both opposite side surfaces 520. In an aspect, the drill guide collarmay have a slot like configuration similar to the collar shown in FIGS.47A and 47B except that the slot length is positioned near the implanttrial opposite side surface 520 as just described regarding the drillguide collar 710 in place of the box chisel of FIG. 43D. In an aspectwith the slot length parallel to the implant trial opposite surface 520,a milling cutter bit may be passed immediately adjacent surface 520while sweeping in a plane generally parallel to the surface 520 and indoing so the milling bit may be caused to project beyond top and bottomsurfaces of the implant trial—effectively preparing a cut similar tothat prepared by the cutting end 628 of FIG. 43B. In yet another aspect,a guide collar including a slot aperture may align a milling bit with anopposite surface 520 yet the slot length may extend generallyperpendicularly away from the surface 520, thereby permittingpreparation along the joint plane by safely milling from a referencesurface 520 and perpendicularly directing the motion of the bit awayfrom the surface 520 (e.g., the other opposite surface 520 may be facingthe sciatic notch).

These are only some versions of alternative embodiments of the implanttrial 514 and cutting element 524 that are applicable to all jointpreparation tools described herein. Other arrangements of channels 522on different surfaces of the implant trial 514 are possible andcontemplated herein. Additionally and alternatively, the implant trial514 and cutting element 524 described in reference to FIGS. 43A-43D mayinclude other features described in reference to the previousembodiments. For example, the implant trial 514 of the presentembodiment may additionally include a cutting element as describedpreviously that extends over the top surface of the implant trial. Also,the cutting element 524 of the present embodiment may include a cuttingelement guide as described previously that is configured to fit within areciprocally shaped opening in the implant trial.

4. Trial Fit Assembly and Cutting Tool with Drill Guiding System

Turning now to FIGS. 44-47, reference is made to an additionalembodiment of a joint preparation tool assembly 700. As seen in FIG. 44,the joint preparation tool assembly 700 includes a trial tool assembly702, a drill guide 704, and a handle assembly 706.

In one aspect, the joint preparation tool assembly 700 is configured toguide a drill bit 708 during distal-proximal translation of the drillbit 708 relative to the drill guide 704 and trial tool assembly 702. Inparticular, the drill guide 704 is similar to as described previouslywith respect to the various embodiments of the cutting tool, except thatthe drill guide 704 includes a guide collar 710 at a distal end 712 ofthe drill guide 712 as opposed to a cutting element. The guide collar710 is a tubular member that is positioned to guide the drill bit 708above a channel 714 formed in a top surface 716 of an implant trial 718,which is located at a distal end 720 of the trial tool assembly 702,when the distal end 712 of the drill guide 704 abuts a proximal end 722of the implant trial 718.

As seen in FIG. 44, the handle assembly 706 is releasably secured to aproximal end 724 of a shaft 726 of the trial tool assembly 702. Thehandle assembly 706 includes drill shank guide 728 that is formed withina body 730 of the handle assembly 706 and is configured to receive andguide a drill bit shank 732 during distal-proximal translation of thedrill bit 708. The drill shank guide 728 is a cylindrical or partiallycylindrical opening or cutout that is sized slightly larger than adiameter of the drill bit shank 732. In this way, as the drill bit shank732 is translated distal-proximal a distal end 734 of the drill bit 708is guided to be received within, and further guided by, an internalpassageway 736 defined within the guide collar 710.

Moving on to FIG. 45, reference is made to the various components of thejoint preparation tool assembly 700 in an uncoupled state. As seen inthe figure, the drill guide 704 is similar to previously describedembodiments of the cutting tool in that it includes a pair of collars738 with protrusions 740 extending radially inward from inner walls 742of the collars 738. The protrusions 740 are configured to fit within andbe guided by a groove 744 formed within the shaft 726 of the trial toolassembly 702. The drill guide 704 additionally includes a drill guideelement 746 at distal end 712 of the drill guide 704 that is configuredto slidingly engage with and be guided by a reciprocally shaped opening748 formed within the implant trial 718.

Turning now to FIG. 46, reference is made to the various components ofthe joint preparation tool assembly 700 in a coupled state. As seen inthe figure, the drill bit 708 may include a stop feature 750 that limitsa depth that the distal end 734 of the drill bit 708 may distally extendrelative to the implant trial 718. The stop feature 750 may bepermanently fixed (e.g., welded) or may be adjustable based on the needsof a particular surgical procedure.

In operation, the joint preparation tool assembly 700 may function asfollows. The trial tool assembly 702 may be delivered into thesacroiliac joint of a patient with or without guidance by a guide wire.The drill guide 704 may be slidingly engaged with the shaft 726 of thetrial tool assembly 702 by fitting the proximal end 724 of the shaft 726within and through the collars 738 such that the protrusions 740 (notshown in FIG. 46) are fitted within the groove 744 of the shaft 726. Thedrill guide 704 may be translated distally while being guided by thecollars 738 of the trial tool assembly 702. As the drill guide 704approaches the implant trial 718, the drill guide element 746 willengage with, and be further guided by, the reciprocally shaped opening748 formed in the implant trial 718. The drill guide 704 will continueits distal translation until the distal end 712 of the drill guide 704abuts the proximal end 722 of the implant trial 718. At this point, theguide collar 710 is adjacent the channel 714 on the top surface 716 ofthe implant trial 718.

Next, the drill bit 708 or, more particularly, the drill bit shank 732may be fitted within the drill bit shank guide 728 in the handleassembly 706. The drill bit 708 may then be distally advanced whilebeing guided by the drill bit shank guide 728 until the distal end 734of the drill bit 708 engages with and is caused to enter the internalpassageway 736 of the guide collar 710. At this point the drill bit 708may be further distally advanced to deliver a bore into a patient's boneor cartilage while being guided by the collar 710 on the drill guide 704and by the drill bit shank guide 728 on the handle assembly 706.

Reference is now made to FIGS. 47A-47B, which are alternativeconfigurations for the guide collar 710. As seen in FIG. 47A, the guidecollar 710 may include generally parallel sidewalls 752 that aregenerally perpendicular to a lower collar wall 754. Defined between thesidewalls 752 and the lower collar wall 754 is a slot or opening 756that is open on a top side 758. Thus, as the drill bit 708 is distallytranslated relative to the guide collar 710, the sidewalls 752 preventthe drill bit 708 from angling laterally in a direction towards one ofthe side surfaces of the implant trial 718. The drill bit 708, however,is free to angle towards or away from the top surface 716 of the implanttrial 718. In this way, the drill bit 708 (i.e., with a drill bitconfigured for milling) may be used to mill or machine a portion of apatient's bone that abuts the top surface 716 of the implant trial 718.

The guide collar 710 of FIG. 47B is similar to the collar of FIG. 47A,except that the guide collar 710 in FIG. 47B includes a top wall member760 on the top side 758 of the guide collar 710. In this way, the guidecollar 710 restrains the movement of the drill bit 708 as it angles awayfrom the top surface 716 of the implant trial 718. Otherwise, the guidecollar 710 functions very similarly to the collar of FIG. 47A. It isnoted that a proximal opening 762 on the guide collar 710 may be sizedlarger than the drill bit 708 a particular amount such that the drillbit 708 may be angled slightly downward towards the implant trial 718.The exact size of the opening 762 may be chosen such that the drill bit708 can angle somewhat downward towards the top surface 716 of theimplant trial 718 without contacting the top surface 716.

Other mechanisms are possible to guide the drill bit 708 duringdistal-proximal movement in drilling or milling a patient's bone. Theaforementioned embodiments are merely exemplary and are not intended tobe limiting. Additionally and alternatively, the trial tool assembly 702and drill guide 704 discussed in the present embodiment may includefeatures described in previous embodiments. For example, while notdiscussed previously, the drill guide 704 may include an alignment guidethat is similar to the cutting guide element discussed previously. Thealignment guide may extend distally from the guide collar 710 and bereceived within a reciprocally shaped opening in the implant trial 718.

III. Methods of Preparing the Sacroiliac Joint for Fusion

The following discussion will focus on various methods of preparing asacroiliac joint for a surgical fusion procedure utilizing the tools anddevices discussed previously. While the discussion focuses on fusing thesacroiliac joint, the methods discussed herein are not limiting; rather,the methods are applicable to the preparation of other joints as well.

A. Preoperative Planning for a Surgical Fusion Procedure

Prior to any joint preparation, a surgeon or other medical person mayselect a suitable procedure to fuse the sacroiliac joint. The proceduremay include fusing the joint with or without delivering an implant inthe joint space. If the surgeon selects a procedure involving deliveryof an implant within the joint space, the surgeon will select an implantconfiguration for delivery into the sacroiliac joint of the patientbased on preoperative or intraoperative data. The data may be the resultof post-processing of raw or other imaging data (e.g. CT or MRI DICOMfiles). The post-processing may include the use of a software program(e.g., 3DSLICER available from http://www.slicer.org) that may be usedfor medical image processing and 3D visualization of image data. Otherdata may include the patient's weight, activity level, and generalhealth.

The preoperative or intraoperative data may assist in the planning andselecting of desirable anchor trajectories (e.g., starting and stoppingpoints on patient's soft tissue and near or within bone tissue), anchordimensions (e.g., length, diameter, head size, washer, thread pitch),implant types and dimensions, and joint preparation tool types,dimensions, and configurations. A particularly system for preparing andfusing the sacroiliac joint may be selected, for example, for ahypermobile joint, which may include an implant or fusion system that isresistant to the expected forces present at that particular patient'ssacroiliac joint. The determination of fixation sufficiency may becalculated based on the patient's data and also on the performanceresults of various bench and/or finite element analysis (“FEA”) testedimplant assembly configurations. For example, a calculated anchor and/orimplant trajectory may be considered and determined from certain patientimaging and post-processing data with an overlayed implant assembly.Further, the implant assembly footprint within the joint plane may beselected as a lower percent of total joint surface to permit sufficientboney fusion across the joint while maintaining a sufficient implantsacral and iliac face surface area to prevent implant subsidence.

Specific measurements and characteristics of the patient's anatomy mayinfluence the selection of a particular joint fusion system. Forexample, the patient's bone density may be measured at numerouslocations in proximity to and surrounding the elements of the implantassembly. Lower bone density (e.g., osteopenia, osteoporosis)corresponding to a T-score lower than −1, sacroiliac joint instability,or hypermobility may require the use of an implant assembly with agreater amount of keel (i.e., the material cross section as defined bythickness of the keel and its length along implant longitudinal axis andalso keels extending a greater distance into both bones defining thesacroiliac joint) and anchor extending across the sacroiliac joint andinto the ilium and sacrum. Additionally, the relative angles between theimplant longitudinal axis and anchor or anchors, and also the relativeangles between multiple anchors (e.g., parallel, divergent, convergent)may be preselected based on the patient's anatomy.

A comparison of the preoperative or intraoperative data (e.g.,sacroiliac joint surface area, joint mobility, loading, bone density,desirable anatomic pathways) and the selected implant assembly and jointpreparation tools may be conducted to ensure or validate compatibilitybefore the manufacture ships the implant system and/or before thesurgeon employs the system in a surgical procedure. After implantassembly and preparation tools validation, the selected assemblies maybe shipped to the surgeon and the surgeon may proceed with the surgicalfusion procedure utilizing the selected assemblies.

B. Fusion of the Sacroiliac Joint via Implant Delivery

In order to fully understand the steps to prepare the sacroiliac jointfor a fusion procedure, this section will detail one, among many,methods of fusion a sacroiliac joint for which the preparation toolsdiscussed herein may be beneficial. To begin, reference is made to FIGS.48A-48B, which depict various bone landmarks adjacent, and defining, thesacroiliac joint 1000 of a patient 1001.

Reference is first made to FIG. 48A, which is a right lateral view of ahip region 1002 of a patient 1001 lying prone, wherein the soft tissue1003 surrounding the skeletal structure 1006 of the patient 1001 isshown in dashed lines. Delivery of an implant into the sacroiliac joint1000 and, thus, preparing of the joint 1000 for delivery of the implantare via a posterior approach to the hip region 1002. FIG. 48B, which isan enlarged view of the hip region 1002 of FIG. 48A, depicts a lateralview of the patient's hip region 1002 reveals certain features of theilium 1005, including the anterior superior iliac spine 2000, the iliaccrest 2002, the posterior superior iliac spine 2004, the posteriorinferior iliac spine 2006, the greater sciatic notch 2008 extending fromthe posterior inferior iliac spine 2006 to the ischial spine 2010, andthe tubercle of iliac crest 2012.

The sacroiliac joint articular region 1044 is shown in dashed lines. Aposterior inferior access region 2016 of the sacroiliac joint articularregion 1044 has a superior end 2018 on the sacroiliac joint line 2019that is between approximately 0 mm and approximately 40 mm inferior theposterior inferior overhang 2020 of the posterior superior iliac spine2004. The posterior inferior access region 2016 of the sacroiliac jointarticular region 1044 has an inferior end 2022 on the sacroiliac jointline that is at approximately the intersection of the posterior inferioriliac spine 2006 with the lateral anterior curved boundary 2024 of thesacrum 1004. In other words, the posterior inferior access region 2016of the sacroiliac joint articular region 1044 has an inferior end 2022on the sacroiliac joint line that is at approximately the superiorbeginning of the greater sciatic notch 2008.

Still referring to FIG. 48B, the sacroiliac joint articular region 1044roughly defines an L-shape that includes a caudal region 1086 and acranial region 1087. Access into the caudal region 1086 of thesacroiliac joint is via the posterior inferior access region 2016 thatextends between corners defined by the superior end 2018 and theinferior end 2022. Access into the cranial region 1087 may beaccomplished by continual, anterior travel in the caudal region 1086until the articular region 1044 turns superiorly into the cranial region1087.

To begin a discussion of implant delivery into the sacroiliac jointarticular region 1044, reference is made to FIG. 48C, which is aclose-up lateral side view of the hip region 1002 of a patient 1001 witha nearest ilium 1005 removed in order to show the sacroiliac jointboundary 3000 defined along the sacrum 1004 and outlining the sacroiliacjoint articular region 1044, and an implant 25 positioned forimplantation within the sacroiliac joint articular region 1044.

As seen in FIG. 48C, boundaries along the sacroiliac joint articularregion 1044 include an inferior boundary segment 3002, an anteriorboundary segment 3004, a superior boundary segment 3006, and a posteriorboundary segment 3008. The inferior boundary segment 3002 is immediatelyadjacent, and extends along, the sciatic notch 2024.

The inferior boundary segment 3002 and anterior boundary segment 3004intersect to form an anterior-inferior corner 3010. The anteriorboundary segment 3004 and superior boundary segment 3006 intersect toform an anterior-superior corner 3012. The superior boundary segment3006 and posterior boundary segment 3008 intersect to form asuperior-posterior corner 3014. The posterior boundary segment 3008 andposterior inferior access region 2016 intersect to form asuperior-posterior corner 3016 of the posterior inferior access region2016. The inferior boundary segment 3002 and posterior inferior accessregion 2016 intersect to form an inferior-posterior corner 3018 of theposterior inferior access region 2016.

The inferior boundary segment 3002 extends between corners 3010 and3018. The anterior boundary segment 3004 extends between corners 3010and 3012. The superior boundary segment 3006 extends between corners3012 and 3014 and provides an access into the cranial portion 1087 ofthe sacroiliac joint. The posterior boundary segment 3008 extendsbetween corners 3014 and 3016. The posterior inferior access region 2016extends between corners 3016 and 3018 and provides an access into thecaudal region 1086 of the sacroiliac joint. The posterior boundarysegment 3008 separates articular region 1044 and extra-articular region3007, which includes the sacral fossa on the sacrum 1004 and thecorresponding iliac tuberosity on the ilium 1005 and defined by theextra-articular region boundary 3009.

In one aspect and as seen in FIG. 48C, the implant 25 may be deliveredvia an implant arm 111 of a delivery tool into the caudal region 1086 ofthe sacroiliac joint articular region 1044. As shown via the implant 25and implant arm 110 shown in solid lines, in one embodiment, the implant25 enters the posterior inferior access region 2016, and is furtheradvanced into the caudal region 1086 of the sacroiliac joint articularregion 1044, in an orientation such that the implant arm 110 and wideplanar members 51 are in the joint plane and the longitudinallyextending edge 3050 of the wide planar member 51 next to the inferiorboundary segment 3002 is generally parallel to, and immediately adjacentto, the inferior boundary segment 3002. Thus, the distal end 43 of theimplant is heading generally perpendicular to, and towards, the anteriorboundary segment 3004.

As shown in FIG. 48C via the implant 25 and implant arm 110 shown indashed lines, in one embodiment, the implant 25 enters the posteriorinferior access region 2016, and is further advanced into the caudalregion 1086 of the sacroiliac joint articular region 1044, in anorientation such that the implant arm 111 and wide planar members 51 arein the joint plane and the longitudinally extending edge 3050 of thewide planar member 51 next to the inferior boundary segment 3002 issomewhere between being generally parallel to the inferior boundarysegment 3002 (as illustrated by the solid-lined implant 25 in FIG. 48C)or forming an angle AJ with the inferior boundary segment 3002 of up toapproximately 50 degrees. Thus, the distal end 43 of the implant shownin dashed lines can be said to head anywhere from generallyperpendicular to, and towards, the anterior boundary segment 3004 toheading generally towards the superior-anterior corner 3012, or pointsin between.

In one embodiment, the implant 25 may be first directed into the jointspace as illustrated by the solid-lined implant 25 in FIG. 48C afterwhich the implant 25 is rotated within the joint space to be positionedsomewhere between, and including, angled position depicted by thedashed-lined implant 25. In other embodiments, the implant 25 may befirst directed into the joint space as illustrated by the dashed-linedimplant 25 in FIG. 48C after which the implant 25 is rotated within thejoint space to be positioned somewhere between, and including, theparallel position depicted by the solid-lined implant 25. Thus, animplant 25 may be delivered non-transversely (i.e., within the joint andnot across the joint) into the caudal region 1086, the cranial portion1087, or partially within each of the caudal and cranial regions 1086,1087 of the sacroiliac joint articular region 1044. Further details ofthe implant delivery can be found in related applications, mentionedpreviously, such as U.S. patent application Ser. No. 12/998,712, whichis incorporated by reference herein in its entirety.

C. Utilization of the Tools and Assemblies Described Herein to Preparethe Sacroiliac Joint for Fusion

Now that an overview of the relevant anatomical landmarks and an examplefusion procedure has been described, the discussion may now focus onpreparing the sacroiliac joint for a fusion procedure. In doing so,reference will be made to FIGS. 49A-49D, among additional figures, whichare steps in the methodology and illustrated in the same transversecross section taken in along a plane extending medial-lateral andanterior posterior. In this cross section, articular surfaces 1016 arecovered by a thick layer of articular cartilage with a joint spaceexisting between them, the FIGS. 49A-49D are simplified for illustrativepurposes and do not show these features to scale.

Now referring primarily to FIG. 49A, an embodiment of the method caninclude the step of placing a patient under sedation prone on atranslucent operating table (or other suitable surface). The sacroiliacjoint 1000 can be locally anesthetized to allow for injecting aradiographic contrast 1046 (as a non-limiting example, Isoview 300radiographic contrast) under fluoroscopic guidance into the inferioraspect of the sacroiliac joint 1000 to outline the articular surfaces1016 of the sacroiliac joint 1000) defined between the sacrum 1004 andilium 1005, the sacroiliac joint 1000 having an interarticular region1044. Injection of the radiographic contrast 1046 within the sacroiliacjoint 1000 can be accomplished utilizing a tubular member 1047 (e.g., asyringe needle) having first tubular member end 1048 which can beadvanced between the articulating surfaces 1016 of the sacroiliac joint1000 and having a second tubular member end 1049 which removably couplesto a hub 1050. The hub 1050 can be configured to removably couple to asyringe barrel 1051 or other device to contain and deliver an amount ofradiographic contrast 1046. In the example of a syringe barrel 1051, thesyringe barrel 1051 can have an internal volume capable of receiving anamount of the radiographic contrast 1046 sufficient for outlining thearticular surfaces 1016 of the sacroiliac joint 1000, for example, underlateral fluoroscopy. A plunger 1052 can be slidingly received within thebarrel 1051 to deliver the radiographic contrast 1046 through thetubular member 1047 into the sacroiliac joint 1000. The tubular member1047 can have a gauge in the range of about 16 gauge and about 20 gaugeand can further be incrementally marked on the external surface to allowdetermination of the depth at which the first needle end 1048 hasadvanced within the sacroiliac joint 1000. As the first needle end 1048advances into the sacroiliac joint 1000 the radiographic dye 1046 can bedelivered from within the syringe barrel 1051 into the sacroiliac joint1000 to allow visualization of the sacroiliac joint 1000 and location ofthe tubular needle 1047 within the sacroiliac joint 1000.

Now referring primarily to FIG. 49B, once the first tubular member end1048 has been sufficiently advanced into the sacroiliac joint 1000 andthe articular surfaces 1016 of the sacroiliac joint 1000 have beensufficiently visualized, the hub 1050 can be removed from the tubularmember 1047 leaving the tubular member 1047 fixed within the sacroiliacjoint 1000 as an initial guide for tools subsequently used to locate orplace the sacroiliac joint implant non-transversely between thearticulating surfaces 1016 of the sacroiliac joint 1000 (e.g., locatethe implant non-transversely to the joint plane 1030 generally definedby the articulating surfaces 1016 of the interarticular region 1044 ofthe sacroiliac joint 1000) or in removal of a portion of the sacroiliacjoint 1000 within the region defined by the articular surfaces 1016 togenerate an implant receiving space 1029. Alternately, one or more guidepins 1013 can be inserted along substantially the same path of thetubular member 1047 for fixed engagement within the sacroiliac joint1000 and used in subsequent steps as a guide(s).

Now referring primarily to FIG. 49C, a small incision 1053 can be madein the skin at the posterior superior, or as to certain embodimentsinferior, aspect of the sacroiliac joint 1000, extending proximal anddistal to the tubular member 1047 along the line of the sacroiliac joint1000 to provide a passage to access the interarticular space between thearticulating surfaces 1016 (see FIG. 49B) of the sacroiliac joint 1000.More specifically, the small incision 1053 can be made along the jointline of the sacroiliac joint 1000 in the tissue covering the posteriorinferior access region 2016 of the sacroiliac joint articular region1044. A cannulated probe 1054 can be slidingly engaged with the tubularmember 1047 (or guide pin 1013) extending outwardly from the sacroiliacjoint 1000 (while the sacroiliac joint may be shown in the figures asbeing substantially linear for illustrative purposes, it is to beunderstood that the normal irregular features of the sacroiliac jointhave not been removed). The cannulated probe 1054 can have a probe body1054 of generally cylindrical shape terminating in a spatulate tip 1055at the end advanced into the sacroiliac joint 1000. A removablecannulated probe handle 1056 couples to the opposed end of the probebody 1054. The spatulate tip 1055 can be guided along the tubular needle1047 or guide wire 1013 into the posterior portion of the sacroiliacjoint 1000 and advanced to the anterior portion of the sacroiliac joint1000 under lateral fluoroscopic visualization. The cannulated probehandle 1056 can then be removed providing the generally cylindricalprobe body 1054 extending outwardly from the sacroiliac joint 1000through the incision 1053 made in the skin.

Alternatively, the probe 1054 can be used to guide, advance or place aneedle, guide wire or other instrument up to, near, or into the joint.

Additionally, in particular embodiments, probe handle 1056 or theopposed end of the probe body 1054, or both, can be configured to havean interference fit or a luer lock hub to communicate with a syringebarrel 1051 in order to advance contrast, in situ curable biocompatiblematerials, stem cells, or etc through the cannulated probe 1054 orcannulated probe handle 1056.

Now referring primarily to FIG. 49D, a passage from the incision 1053(see FIG. 49C) to the sacroiliac joint 1000 can be generated byinserting a cannula 1057 into the incision. A soft tissue dilator 1058having a blunt end 1059 can be advanced over the probe body 1054, or aplurality of soft tissue dilators of increasing size, until the bluntend 1059 of the soft tissue dilator 1058 and the corresponding cannulaend contact the posterior aspect of the sacroiliac joint 1000. Morespecifically, in one embodiment, the ends of the dilator 1058 andcannula 1057 contact the joint line 2019 of the sacroiliac joint 1000 atthe posterior inferior access region 2016 of the sacroiliac jointarticular region 1044. The soft tissue dilator 1058 can be removed fromwithin the cannula 1057. The external surface of the cannula 1057 can besufficiently engaged with the surrounding tissue to avoid having thetissue locate with in the hollow inside of the cannula 1057. Anon-limiting embodiment of the cannula 1057 provides a tubular bodyhaving substantially parallel opposed side walls which terminate in aradius at both ends (lozenge shape) into which a plurality of differentjigs can be inserted. Alternatively, as a non-limiting example,according to particular embodiments, cannula 1057 and correspondingdilators 1058 and alignment jigs 1060 can be configured to have tubularbodies with an elliptical or circular cross section.

In some embodiments, the cannula 1057 may be additionally configured tohave within or near its walls a light source such as, for example, afiberoptic or a LED light source to assist in visualization of theworking area. Also, in some embodiments, irrigation and suction tubingmay communicate with the inside passage of cannula 1057.

At this stage, additional tools and methods may be employed to provideaccess to the sacroiliac joint 1000 as described in U.S. patentapplication Ser. No. 13/475,695 filed May 18, 2012 entitled “SYSTEMS FORAND METHODS OF FUSING A SACROILIAC JOINT,” which is hereby incorporatedby reference in its entirety. For example, drill jigs may be furtheradvanced over the probe body 1054 to align a drill or other jointpreparation tool. Accordingly, the discussion will now focus onemploying the tools and devices described in previous sections of thisapplication.

-   -   Now referring primarily to FIGS. 49E-49G, a cannula alignment        jig 1060 can be advanced over the probe body 1054 (or guide pins        1013) and received within the cannula 1057. Substantially,        identical cross hairs 1063, 1064 can be disposed on the upper        jig surface 1065 and the lower jig surface 1066. Alignment of        the cross hairs 1063, 1064 under x-ray with the sacroiliac joint        1000 can confirm that the cannula 1057 has proper orientation in        relation to the paired articular surfaces 1016 of the sacroiliac        joint 1000. The cannula 1057 properly oriented with the paired        articular surfaces 1016 can then be disposed in fixed relation        to the sacroiliac joint by placement of fasteners through the        cannula 1057 into the sacrum 1004 or the ilium 1005.    -   Now referring to FIGS. 49H and 49I, a first drill jig 1067 can        be advanced over the probe body 1054 (or guide pins 1013) and        received within the cannula 1057. The probe body 1054 (or guide        pins 1013) extending outwardly from the sacroiliac joint 1000        passes through a drill guide hole 1068 of the first drill jig        1067 (or a plurality of guide pins 1013 can extend through a        corresponding plurality of guide pin holes 1069). The drill        guide hole 1068 can take the form of a circular hole as shown in        the Figures, a slot, or other configuration to restrict the        movement of a drill bit 1062 within the drill jig 1067 and        provide a guide for a drill bit 1062 in relation to the        sacroiliac joint 1000. Guide pin holes 1069 can receive guide        pins which can be positioned between the articular surfaces 1016        of the sacroiliac joint 1000 to demarcate the zone of desired        treatment or safe working zones while using, for example,        lateral fluoroscopy. As a non-limiting example, a first guide        pin 1013 can be advanced through a first guide pin hole 1069, or        alternatively a guide pin 1013 is first inserted into the        sacroiliac joint 1000 and subsequently a guide jig 1067 is        advanced over the guide pin 1013, the first guide pin 1013 can        enter near inferior end 2022 of the posterior inferior access        region 2016 of the sacroiliac joint articular region 1044 via        the sacroiliac joint line 2019 to border a portion of the        greater sciatic notch 2008 thereby allowing a medical person,        computer guided surgical system, or other observer to more        easily highlight under x-ray a border which should not be        crossed during the procedure due to the presence of nerve and        other structures. Additionally, as a non-limiting example, first        guide pin 1013 can configured as an electrode, insulated from        the operator and the patient's soft tissues, and may be        connected to a monitor to signal to an operator or surgeon when        implant 12, configured with a stimulating electrode (NM), e,g.,        as shown and described in U.S. Provisional Patent Application        61/860,185, comes into contact with first guide pin. Similarly,        a second guide pin 1013 can be placed in another guide pin hole        1069 to demarcate a second limit to a desired zone of treatment,        or safe working zone. For example, a second guide pin 1013 can        enter near the superior end 2018 of the posterior inferior        access region 2016 of the sacroiliac joint articular region 1044        via the sacroiliac joint line 2019 to be positioned to border an        area of the sacroiliac joint 1000 such as a transition zone        between the extra-articular 3007 and the interarticular region        1044 which, for example, has been highlighted by contrast        material as above described.    -   Referring to FIGS, 49J-49R, a cannula 1057 may be used to        facilitate access to the surgical region during a procedure to        implant the implant assembly 14 (not shown). In one embodiment,        the cannula 1057 may be used in conjunction with a sacroiliac        joint repair procedure via a known surgical access region        including, but not limited to, the posterior inferior access        region 2016 as illustrated in FIGS. 49J-49R. The cannula 1057        may include a cannula body 1057H forming a wall enclosing an        internal volume 1057J, which opens to a proximal opening 1057A        and a distal opening 105713. Upon insertion of the cannula 1057        within the surgical access region, the internal volume 1057J may        be maintained, thereby functioning as an opening through which        surgical instruments, appliances, fasteners, and any other        associated surgical equipment or supplies may be inserted or        removed and through which the surgical procedure may be visually        monitored.    -   The outer surface of the cannula body 1057H may include one or        more contoured regions or projections to enhance the close fit        of the cannula 1057 between the skeletal structures surrounding        the surgical access region 2016. The outer surface of the body        1057H may form a cannula sacral contour 1057C on one side and        may additionally form a cannula iliac contour 1057D on a side        opposite to the cannula sacral contour 1057C. The cannula 1057        may also include a distal projection 1057E which extends        distally beyond the cannula sacral contour 1057C and may be        shaped to fit within a portion of the greater sciatic notch 2008        (see FIG. 49P). In addition, the outer distal surface of the        cannula body 1057H may form a PSIS contact area 1057F to enhance        the fit of the portion of the cannula 1057 contacting the        posterior superior iliac spine (PSIS) 2004 (see FIG. 49N).    -   The cannula body 1057H may further define one or more additional        bores configured to reversibly receive handles and/or fasteners        used to situate the cannula within the surgical region and/or to        reversibly receive fasteners used to fix the cannula in place        within the surgical region during the surgical procedure. The        cannula body 1057H may define a fastener bore 1057K passing        through the cannula body 1057H from the outer surface into the        internal volume 1057J of the cannula 1057. The cannula bore may        open at one end to a cannula fastener bore proximal opening        1057G, which may be in communication with the internal volume        1057J of the cannula 1057. The cannula bore may also open at an        opposite end to a cannula fastener bore distal opening 1057L        which may be further configured to permit a fastener 1057Z to i)        extend generally perpendicular to the cannula PSIS contact area        1057F; and/or, ii) be in a divergent relation relative to distal        projection 1057E. Furthermore, the cannula 1057 may have a        handle 1057Y extending from the cannula body 1057H for        inserting, removing, and/or otherwise manipulating the cannula        1057 during a surgical procedure. As illustrated in FIG. 49J,        the handle 1057Y may be reversibly attached to the cannula body        1057 via a handle bore 1057M formed with the cannula body 1057H.        The handle bore 1057M may be provided with fastener features        including, but not limited to, threads, that may cooperatively        engage corresponding fastener features at a distal end 1057N of        the handle 1057Y in order to implement the reversible attachment        of the handle 1057Y to the cannula 1057.    -   Referring again to FIGS. 49J to 49R, a surgical procedure        employing the cannula 1057 may be conducted using a method        described herein below. A cannula 1057 may be positioned near a        sacroiliac joint line 2019 and in an area including the        posterior inferior access region 2016 such that the sacroiliac        joint line 2019 may be visible and/or accessible via a cannula        proximal opening 1057A, as illustrated in FIG. 49O. The cannula        1057 may be further positioned to align the distal extension        1057E with a portion of the greater sciatic notch 2008, as        illustrated in FIG. 49P. The cannula 1057 may be further        positioned to align the cannula PSIS contact area 1057F with a        portion of a posterior superior iliac spine 2004 as illustrated        in FIG. 49N. The cannula 1057 may then be disposed in fixed        relation to the sacroiliac joint by placement of fasteners 1057Z        through the cannula 1057 into the sacrum 1004 or the ilium 1005,        as illustrated in FIG. 49P.

In certain embodiments of the method, an amount of articular cartilageor other tissues from between the articular surfaces of the sacroiliacjoint 1000 can be removed sufficient to allow embodiments of thesacroiliac joint implant to be implanted in replacement of the removedarticular cartilage or tissue. Because the method removes thedegenerative articular cartilage or tissue between the articularsurfaces of the sacroiliac joint 1000, the articular surfaces of thesacroiliac joint 1000 can remain intact or substantially intact allowingthe sacroiliac joint implant to be non-transversely located between thearticular surfaces of the sacroiliac joint 1000.

Reference is now made to FIG. 50A, which depicts a joint preparationtool 4000 including a tooling head 4002, as described in FIGS. 9-10,approaching the sacroiliac joint 1000. The joint preparation tool 4000,in particular, includes a cutting element 4004 that outwardly extendsfrom a shaft 4006 at the distal end of the tooling head 4002. Thecutting element 4004 includes a sharpened proximal edge 4008 such that acutting stroke occurs with a proximal retraction of the jointpreparation tool 4000.

As seen in FIG. 50A, the joint preparation tool 4000 is orientedrelative to sacroiliac joint articular region 1044 such that theoutwardly extending cutting element 4004 is positioned parallel to thejoint plane 1030. That is, each of the side walls the cutting element4004 is oriented between the articular surfaces of the joint 1000 andthe proximal edge 4008 is, initially, oriented transversely across thejoint plane 1030. As illustrated in FIG. 50B, the joint preparation tool4000 is advanced into the sacroiliac joint articular region 1044 in thepreviously described orientation.

Now reference is made primarily to FIG. 50C, which is a similar view tothat of FIG. 48C, except that instead of an implant being delivered intothe sacroiliac joint 1000, the joint 1000 is being prepared for implantdelivery. As seen in the figure, the distal end of the tooling head 4002may enter the posterior inferior access region 2016 and extend into thecaudal region 1086 of the sacroiliac joint articular region 1044. As anexample and as seen by the solid line depiction of the tooling head4002, the head 4002 may be delivered into the caudal region 1086 suchthat the shaft 4006 is generally adjacent and parallel to the inferiorboundary segment 3002. At a sufficient depth, the joint preparation tool4000 may be rotated within the joint plane (as seen by the broken linedepiction of the joint preparation tool 4000) such that the shaft 4006angles the cutting element 4004 towards the cranial region 1087 of thearticular region 1044. This and other movements will cause the proximaledge 4008 of the cutting element 4004 to cut into or shear the articularcartilage from the articular surfaces of the sacroiliac joint articularregion 1044.

As another example of preparing the articular region 1044 once the tool4000 is positioned within the articular region 1044, reference is madeto FIG. 50D, which depicts the joint preparation tool 4000 fully in intothe articular region 1044 such that the shaft 4006 of the tooling head4002 is adjacent and parallel to the inferior boundary segment 3002 andthe cutting element 4004 is adjacent the anterior-inferior corner 3010.In this orientation, the cutting element 4004 extends from the shaft4006 towards the cranial region 1087 of the articular region 1044. It isnoted that insertion of the tool 4000 into the articular region 1044causes an initial abrasion to the articular cartilage in the portions ofthe articular region 1044 where the tool 4000 is inserted. To furtherprepare the articular region 1044, a force F1 may be applied to jointpreparation tool 4000 in a direction perpendicular to the extension ofthe shaft 4006 and in a direction towards the cranial region 1087. Asseen in FIG. 50E, which depicts the joint preparation tool 4000 movedsuperiorly according to the applied force F1, the cutting element 4004is now in contact with additional articular cartilage that was notpreviously abraded by the insertion of the tool 4000 into the articularregion 1044. At this point, a force F2 may be applied proximally on thejoint preparation tool 4000.

As seen in FIG. 50F, the force F2 and the proximal retraction of thetooling head 4002 from the articular region 1044 will cause articularcartilage in-line with the cutting element 4004 to be cut or otherwisesheared from the articular surfaces of the articular region 1044 leavinga prepared joint surface 4010. At this point, the joint preparation toolhaving a curette-type tooling head may be used to remove the abradedarticular cartilage in the joint space by any number of methods.

The previously mentioned steps may be repeated in order to increase thesize of the prepared joint surface 4010 as may be needed for aparticular surgical procedure. For example, a joint preparation tool4000 having a tooling head 4002 with a larger outwardly extendingcutting element 4004 may be subsequently used to prepare an even largerjoint surface 4010.

Now primarily referring to FIG. 51A, the joint preparation tool 4000previously described may be used to make keel-cuts generallyperpendicularly into the sacrum 1004 and/or the ilium 1005. As seen inthe figure, which is a transverse cross section of the sacrum 1004 andthe ilium 1005 taken in along a plane extending medial-lateral andanterior posterior, the joint preparation tool 4000 may be deliveredinto the sacroiliac joint articular region 1044, as described previouslyin FIGS. 50A-50B, such that the cutting element 4004 extends from theshaft 4006 of the tooling head 4002 parallel to the joint plane 1030. Inthis orientation, the proximal edge 4008 of the cutting element 4004extends across the joint plane 1030. Once the joint preparation tool4000 is at a sufficient depth within the articular region 1044, as seenin FIG. 51A, the shaft 4006 of the tool 4000 may be rotated such thatthe cutting element extends within either the sacrum 1004 or the ilium1005 (cutting element extends within ilium 1005 in FIG. 51A) and isoriented perpendicular to the joint plane 1030. Next, a force F3 may beproximally applied (e.g., via a slap hammer assembly) to the jointpreparation tool 4000 such that the proximal edge 4008 of the cuttingelement 4004 cuts a channel, groove, or other feature as defined by theshape of the proximal edge 4008 into the bone of the ilium 1005. As seenin FIG. 51B, the proximal retraction of the joint preparation tool 4000forms a receiving space 4012 within the bone of the ilium 1005 for usein a particular fusion procedure. While FIG. 51B depicts the cuttingelement 4004 only partially retracted from the articular region 1044,the cutting element 4004 may be fully retracted such that the keel-cutsforming the receiving space 4014 extend to the proximal end of the jointline 1030.

Alternatively and as seen in FIG. 51C, which is the same as FIG. 51Bexcept the shaft 4006 of the joint preparation tool 4000 is rotatedabout ninety degrees, the tooling head 4002 may be removed from thearticular region 1044 after the ninety degree rotation by a proximalforce F4. Thus, the tooling head 4002 is removed from the joint withoutperforming a full keel-cut that would extend the receiving space 4012 tothe proximal end of the joint line 1030. Turning to FIG. 51D, whichdepicts the receiving space 4012 after the joint preparation tool 4000has been proximally withdrawn; the receiving space 4012 may be filledwith a biological material 4014 such as an alto/auto-graft, syntheticbiologic, or scaffold, among other materials. Next, a bone tamp 4016 orother device may be used to apply a distal force F5 along the joint line1030 so as to compress the biological material 4014 into the receivingspace 4012. As seen in FIG. 51E, the bone tamp 4016 may be compressedalong the joint line 1030 up to a depth of the keel-cut, among otherpossible depths, such that the biological material 4014 may compressacross the articular surface of the sacrum 1004 and the groove formed inthe receiving space 4012.

In certain embodiments of the method, keel-cuts can be made in either orboth of the sacrum 1004 and the ilium 1005 and such a decision will bebased on the particular fusion procedure and the type and configurationof an implant to be delivered into the joint. For example, an implanthaving coplanar wing member may require dual keel-cuts where both thesacrum 1004 and the ilium 1005 are cut for the subsequent delivery ofthe implant. In such an example and referring to FIG. 52A, a jointpreparation tool 4000 having a tooling head 4002 with dual-cuttingelements 4004, as described in reference to FIG. 13, may be employed.Similar to as discussed previously, the joint preparation tool 4000having dual-cutting elements 4004 may be delivered into the sacroiliacjoint articular region 1044 with the outwardly extending cuttingelements 4004 positioned within the joint plane 1030 such that theproximal edges 4008 extend across the joint line 1030. Once the jointpreparation tool 4000 is delivered into the articular region 1044 at anappropriate depth, as seen in FIG. 52A, the tool 4000 may be rotatedabout ninety degrees such that the cutting elements extend generallyperpendicularly into the sacrum 1004 and the ilium 1005. Next, as seenin FIG. 52B, the joint preparation tool 4000 may be proximally retractedby a force F6 (e.g., via a slap hammer) such that the dual-cuttingelements 4004 form opposing channels 4018 in the sacrum 1004 and theilium 1005 that match the shape of an implant to be delivered in thesurgical procedure.

In certain embodiments, the dual-cutting elements 4004 are identical inshape and size. In other embodiments, the dual-cutting elements 4004 maybe differently configured based on the physical characteristics of thebone type to be cut, the implant to be delivered, etc. That is, sincethe ilium 1005 is generally a harder bone than the sacrum, a differenttype of cutting edge configuration may be used on one of the cuttingelements 4004.

Now the discussion will focus on methods of preparing the sacroiliacjoint 1000 for a surgical fusion procedure with a joint preparation toolassembly including a trial tool assembly and a cutting tool as describedin reference to FIGS. 27-47.

Referring primarily to FIG. 53A, a trial tool assembly 4022 having animplant trial 4024 at a distal end of the assembly 4022 may be deliveredinto the sacroiliac joint articular region 1044 of a patient. The trialtool assembly 4022 may be guided into the articular region 1044 by aguide wire (not shown) that was previously delivered into the joint bypreviously described methods. In particular, the guide wire may bereceived within a bore that extends from a distal end to a proximal endof the implant trial 4024. The implant trial 4024 may be deliveredwithin the joint plane 1030 such that the planar top and bottom surfaces4026 are parallel to the joint plane 1030 and the opposite side surfaces4028 of the implant trial 4024 are perpendicular to the joint plane1030.

The implant trial 4024 may be forcibly delivered into the articularregion 1044 by using a hammer or mallet to strike an impact plate (notshown) at a proximal end of the joint preparation tool assembly 4020.And, in certain embodiments, a trial impact rod assembly (not shown) maybe used in conjunction with the trial tool assembly 4022 to providestiffness during the forceful delivery of the implant trial 4024 withinthe articular region 1044.

The implant trial 4024 is used to determine an appropriate fit of animplant. So, implant trials 4024 of increasingly larger size may bedelivered into the articular region 1044 until an implant trial 4024 ischosen that appropriately fits the top and bottom surfaces 4026 of theimplant trial 4024 against the articular surfaces of the articularregion 1044.

Referring primarily to FIG. 53B, which depicts the implant trial 4024positioned within the articular region 1044, a cutting tool 4030 may beslidingly engaged with a shaft 4032 of the trial tool assembly 4022 andtranslated distally on the shaft 4032. As seen in FIG. 53B and asdescribed previously, the cutting tool 4030 is guided along the shaft4032 in a single orientation such that it will be guided within achannel (not shown) on the top surface 4026 of the implant trial 4024.The channel is configured to guide the cutting tool 4030 such that acutting element 4034 of the cutting tool 4030 extends generallyperpendicular to the top surface 4026 of the implant trial 4024. Thus,as seen in FIG. 53C, as the cutting element 4034 advances distally intothe channel of the implant trial 4024 and within the articular region1044, the cutting element 4034 extends and cuts into the articularsurface of either the sacrum 1004 or the ilium 1005. A reciprocatingmotion may be employed.

While, as seen in FIG. 53C, the cutting element 4034 extends and cutsinto the ilium 1005 during a distal stroke of the cutting tool 4030, theprocess may be similarly performed with respect to the sacrum 1004.Alternatively, a cutting tool 4030 with dual-cutting elements 4034 maybe employed to deliver simultaneous and opposing cuts into both thesacrum 1004 and the ilium 1005. In such an embodiment of the jointpreparation tool assembly 4020 with dual-cutting elements 4034 (and,thus, dual-channels in the implant trial 4024) the individual cuttingelements 4034 may be the same or different. The individual cuttingelements 4034 may, for example, be different types and configurations ofcutting elements 4034 since the ilium 1005 is a generally harder bonethan the sacrum 1004. Additionally, cutting tools 4030 with increasinglylarger cutting elements 4034 may be employed such that initial cuts aresmaller and of a shallower depth into the articular surfaces whilesubsequent cuts are larger and of a deeper depth into the articularsurfaces of the sacrum 1004 and ilium 1005.

After employing the joint preparation tool 4020 to make appropriatekeel-cuts, as seen in FIG. 53D, the tool 4020 may be removed from thearticular region 1044 leaving one or more channels 4036 that match animplant to be delivered into the joint 1000.

As stated previously, the various tools and assemblies discussed hereinmay be used independently or in combination with each other. Thus, incertain embodiments and at various steps within the methodology theanchor arm assembly 258, as discussed in reference to FIGS. 24-25, maybe employed with any of the joint preparation tools to deliver ananchoring element 282 across the sacroiliac joint. The anchoring armassembly 258 may, for example, orient the anchoring element 282 to bedelivered first through the ilium, transversely across the joint line ofthe sacroiliac joint, and then through the sacrum. Alternatively, theanchoring arm assembly 258 may orient the anchoring element 282 to bedelivered first through the sacrum, transversely across the joint lineof the sacroiliac joint, and then through the ilium.

Understandably, other instruments can be utilized separately or incombination during the course of any of the steps of the methodology,.e.g., for the removal of articular cartilage or tissue betweenarticular surfaces, such as any of the tools previously described or anyof: endoscopy tools, box chisels, side cutting router bits, burs,flexible burs and bits, hole saws, key hole saw, medical bone chainsawosteotome, curettes, lasers (e.g., C02, Neodymium/Y AG(yttrium-aluminum-garnet), argon, and ruby), electrosurgical equipmentemploying electromagnetic energy (the cutting electrode can be a finemicro-needle, a lancet, a knife, a wire or band loop, a snare, anenergized scalpel, or the like) where the energy transmitted can beeither monopolar or bipolar and operate with high frequency currents,for example, in the range of about 300 kHz and about 1000 kHz whether aspure sinusoidal current waveform where the “crest factor” can beconstant at about 1.4 for every sinus waveform, and a voltage peak ofapproximately 300 V to enable a “pure” cutting effect with the smallestpossible coagulation effect or as amplitude modulated current waveformswhere the crest factor varies between 1.5 and 8, with decreasing crestfactors providing less of a coagulation effect. Electrosurgicalwaveforms may be set to promote two types of tissue effects, namelycoagulation (temperature rises within cells, which then dehydrate andshrink) or cut (heating of cellular water occurs so rapidly that cellsburst). The proportion of cells coagulated to those cut can be varied,resulting in a “blended” or “mixed” effect. Additionally, a fullyrectified current, or a partially rectified current, or a fulgurationcurrent where a greater amount or lateral heat is produced can beemployed to find the articular surfaces of the joint and aid inadvancing a probe or guide wire into a position in between thearticulating surfaces. These currents can effectively degrade thecartilage and allow advance into the joint without grossly penetratingmuch beyond the cartilage.

The foregoing merely illustrates the principles of the embodimentsdescribed herein. Various modifications and alterations to the describedembodiments will be apparent to those skilled in the art in view of theteachings herein. It will thus be appreciated that those skilled in theart will be able to devise numerous systems, arrangements and methodswhich, although not explicitly shown or described herein, embody theprinciples of the embodiments described herein and are thus within thespirit and scope of the present disclosure. From the above descriptionand drawings, it will be understood by those of ordinary skill in theart that the particular embodiments shown and described are for purposesof illustrations only and are not intended to limit the scope of thepresent disclosure. References to details of particular embodiments arenot intended to limit the scope of the disclosure.

What is claimed is:
 1. A method of surgically preparing a sacroiliacjoint having a sacrum, an ilium, and a sacroiliac joint space definedtherebetween for a surgical fusion procedure, the method comprising: a)approaching the sacroiliac joint space with a joint preparation toolcomprising: an implant trial tool assembly comprising an implant trialat a distal end of the joint preparation tool and an implant trial shaftextending proximally from the implant trial, the implant trialcomprising a length extending between a proximal end and a distal end ofthe implant trial, a first top surface, and a first bottom surfacegenerally opposite the first top surface; and a cutting tool configuredto releasably and slidably couple with the implant trial tool assembly,the cutting tool comprising a cutting element at a distal end of thecutting tool and a cutting shaft extending proximally from the cuttingelement, the cutting element comprising a second length extendingbetween a proximal and a distal end, wherein the implant trial toolassembly is configured to guide the cutting tool during distal-proximaltranslation; b) delivering at least a portion of the implant trialnon-transversely into the sacroiliac joint space, the implant trialbeing oriented in the sacroiliac joint space such that the first top andbottom surfaces are generally coplanar with a joint plane of thesacroiliac joint space; and c) causing the cutting tool to be distallydriven relative to the implant trial tool assembly such that the cuttingelement makes a cut extending into at least one of the sacrum or theilium.
 2. The method of claim 1, wherein the implant trial tool assemblyis configured to guide the cutting tool during the distal-proximaltranslation such that as the cutting element distally advances relativeto the implant trial, at least a portion of the cutting element extendsgenerally over and perpendicularly outward from the first top surface ofthe implant trial.
 3. The method of claim 1, wherein the implant trialfurther comprises a channel formed in the first top surface that extendsat least a portion of the first length of the implant trial, the channelguiding the cutting element during the distal-proximal translation. 4.The method of claim 3, wherein the cutting element is partiallypositioned within the channel.
 5. The method of claim 4, wherein thecutting element further comprises a cutting element guide extending atleast a portion of the second length and fitting within a reciprocatingportion of the channel.
 6. The method of claim 5, wherein the channeldefines an opening on a proximal end of the implant trial such that asthe cutting element is distally driven relative to the implant trial,the cutting element is received within the channel and the cuttingelement guide is received within the reciprocating portion of thechannel.
 7. The method of claim 6, wherein the reciprocating portion ofthe channel comprises a cylindrical portion.
 8. The method of claim 5,wherein the cutting element guide fitting within the reciprocatingportion of the channel restrains the cutting element from rotatingrelative to the implant trial.
 9. The method of claim 3, wherein thechannel does not extend to and form an opening in the first bottomsurface.
 10. The method of claim 1, wherein the implant trial furthercomprises a bore extending through the implant trial from the distal tothe proximal end and configured to receive and be guided into thesacroiliac joint space by a guide wire.
 11. The method of claim 10,wherein the implant trial shaft is offset from a central portion of aproximal end of the implant trial.
 12. The method of claim 11, whereinthe implant trial shaft includes a groove formed within the implanttrial shaft, the groove being generally coaxial with the bore.
 13. Themethod of claim 1, wherein the implant trial shaft includes a grooveformed within and extending lengthwise of the implant trial shaft, thecutting tool including a protrusion that engages with the groove duringdistal-proximal translation of the cutting tool relative to the implanttrial tool assembly.
 14. The method of claim 13, wherein the engagementof the protrusion and the groove prevents rotation of the cutting toolrelative to the implant trial tool assembly.
 15. The method of claim 1,wherein the joint preparation tool further comprises: a trial impact rodassembly comprising an implant trial extension member at a distal end ofthe trial impact rod assembly, a trial impact shaft coupled to andextending proximally from the implant trial extension member, and atrial impact cavity extending through the implant trial extension memberand through at least a portion of the trial impact shaft, the trialimpact cavity configured to receive the implant trial shaft such thatthe implant trial and the implant trial extension member abut each otherin a particular arrangement.
 16. The method of claim 15, wherein theimplant trial extension member includes a second top surface, a secondbottom surface opposite the second top surface, and a second thicknessdefined between the second top and second bottom surfaces, wherein inthe particular arrangement the first top surface aligns with the secondtop surface to form a generally smooth transition between the surfaces.17. The method of claim 15, wherein, in the particular arrangement,corresponding features on a distal end of the implant trial extensionmember and on the proximal end of the implant trial engage with eachother to restrict rotational movement of the trial impact rod assemblyrelative to the implant trial tool assembly.
 18. The method of claim 17,wherein the corresponding features include a stud member and a boreconfigured to receive the stud member within the bore.
 19. The method ofclaim 15, wherein the trial impact shaft includes a lock feature that isconfigured to secure a position of the implant trial shaft when theimplant trial shaft is received within the trial impact cavity.
 20. Themethod of claim 15, wherein a proximal end of the trial impact rodassembly includes a handle engagement feature configured to bereleasably secured to a handle.
 21. The method of claim 1, wherein thecutting tool simultaneously makes a cut into the sacrum and the ilium.22. The method of claim 1, wherein the cutting tool makes a cut intoonly one of the sacrum or the ilium.
 23. The method of claim 1, whereinthe implant trial shaft comprises a first cylindrical rod, and thecutting shaft comprises a second cylindrical rod.
 24. The method ofclaim 1, further comprising: d) delivering an implant into thesacroiliac joint space.
 25. The method of claim 24, wherein at least aportion of the implant occupies a space resulting from the cut extendinginto at least one of the sacrum or the ilium.
 26. The method of claim25, wherein the at least a portion comprises a keel of the implant. 27.The method of claim 24, wherein the implant approximates a shape andsize of the implant trial.
 28. The method of claim 1, wherein theimplant trial further comprises a first side surface, a second sidesurface, and a guide wire bore, the first side surface extending betweenthe first top surface and the first bottom surface on a first side ofthe implant trial, the second side surface extending between the firsttop surface and the first bottom surface on a second side of the implanttrial that is opposite the first side, the guide wire bore extendingthrough the implant trial from the distal to the proximal end andconfigured to receive and be guided into the sacroiliac joint space by aguide wire.
 29. The method of claim 28, wherein the implant trialfurther comprises a channel formed in the first top surface that extendsat least a portion of the first length of the implant trial, the channelcomprising a head region and a contracted neck region, wherein thecutting element further comprises a cutting element guide extending atleast a portion of the second length, the cutting element guideconfigured to fit within the head region and the contracted neck region.30. The method of 29, wherein the cutting element guide is configured tobe received within the head region and the contracted neck region whenthe cutting element distally converges with the implant trial such that,once converged, the cutting element is restrained from rotating relativeto the implant trial via the cutting element guide fitting within thehead region and the contracted neck region.
 31. A method of surgicallypreparing a sacroiliac joint having a sacrum, an ilium, and a sacroiliacjoint space defined therebetween for a surgical fusion procedure, themethod comprising: a) approaching the sacroiliac joint space with ajoint preparation tool comprising: an implant trial tool assemblycomprising an implant trial at a distal end of the joint preparationtool and an implant trial portion extending proximally from the implanttrial, the implant trial comprising a length extending between aproximal end and a distal end of the implant trial; and a cutting toolconfigured to releasably couple with the implant trial tool assembly,the cutting tool comprising a cutting element at a distal end of thecutting tool and a cutting tool portion extending proximally from thecutting element, the cutting element comprising a second lengthextending between a proximal and a distal end, wherein the implant trialtool assembly is configured to guide the cutting tool during step c); b)delivering at least a portion of the implant trial non-transversely intothe sacroiliac joint space; and c) causing the cutting tool to beactuated relative to the implant trial tool assembly such that thecutting element makes a cut extending into at least one of the sacrum,the ilium or the sacroiliac joint space.
 32. The method of claim 31,wherein the cut extends into the sacroiliac joint space and the jointpreparation tool further comprises a guide assembly having a guidecomprising a first passageway configured to guide the cutting elementcomprising a drill or mill bit during cutting of the sacroiliac jointspace.
 33. The method of claim 32, wherein the first passageway is agenerally cylindrical bore.
 34. The method of claim 33, wherein thecutting element having a longitudinal axis is caused to be coaxiallydisplaced relative to a central axis of the first passageway during aconstrained distal-proximal translation.
 35. The method of claim 34,wherein the constrained distal-proximal translation is such that thelongitudinal axis of the cutting element and the central axis of thepassageway remain coaxially aligned during step c).
 36. The method ofclaim 34, wherein the constrained distal-proximal translation is suchthat a stop coupled with the cutting element limits a depth of distalextension of the distal end of the cutting element relative to theimplant trial during step c).
 37. The method of claim 32, wherein thefirst passageway comprises a slot-like configuration comprising a slotlength extending generally perpendicular to a length of the firstpassageway.
 38. The method of claim 37, wherein prior to step c), themethod further comprises orienting the slot length generally parallelwith a plane of the sacroiliac joint space.
 39. The method of claim 38,wherein the implant trial comprises a first surface extending the lengthand a second surface opposite the first surface and extending thelength, and wherein prior to step c), the method further comprisesorienting the implant trial such that the first surface faces a sciaticnotch and the slot length extends in a direction generally perpendicularto the second surface thereby permitting preparation along the plane ofthe sacroiliac joint by directing a motion of the cutting element awayfrom both the second surface and the sciatic notch.
 40. The method ofclaim 32, wherein the guide assembly is configured to releasably andslidably couple with the implant trial tool assembly, and wherein theguide is supported by a guide shaft extending proximally from the guide.41. The method of claim 31, wherein the cutting tool portion includes adogleg portion such that the cutting tool portion and the trial portionare offset from each other.
 42. The method of claim 31, wherein the cutextends into the sacroiliac joint space and the cutting elementcomprises a box-chisel configuration.
 43. The method of claim 31,wherein the implant trial comprises a first side and a second sideopposite the first side each extending the length, and wherein thecutting element includes two T-shaped members, wherein a first T-shapedmember is on the first side and a second T-shaped member is on thesecond side of the implant trial, and during step c) the cutting elementmakes the cut comprising multiple cuts simultaneously into each of thesacrum and ilium.
 44. The method of claim 31, wherein the implant trialfurther comprises a channel formed in a surface that extends at least aportion of the length of the implant trial, the channel guiding thecutting element during step c).
 45. The method of claim 44, wherein thechannel is formed in the first top surface of the implant trial, thechannel does not extend to and form an opening in the first bottomsurface.
 46. The method of claim 31, wherein the implant trial comprisesa first side and a second side opposite the first side, each of thefirst and second sides extending the length, and wherein the cuttingelement includes at least a first member and a second member, whereinthe first member is guided along the first side and the second member isguided along the second side of the implant trial, and during step c)the cutting element makes the cut comprising multiple cutssimultaneously into each of the sacrum and ilium.
 47. The method ofclaim 46, wherein each of the first member and second member of thecutting element comprises an implant trial engagement end and a cuttingend, the implant trial engagement end includes a neck member thatextends to a wide-member that is slidingly and matingly received withina channel formed in the implant trial.
 48. The method of claim 47,wherein a cutting end of the first member of the cutting elementtransitions generally ninety degrees from the implant trial engagementend of the first member of the cutting element and extends generallyparallel with a first side surface comprising the first side of theimplant trial.
 49. The method of claim 48, wherein the implant trialcomprises a third side and a forth side opposite the third side eachextending the length, the third side extending between a first side edgeof the first side and a first side edge of the second side, the fourthside extending between a second side edge of the first side and a secondside edge of the second side, wherein the cutting end terminates in afirst cutting tip that extends beyond the third surface of the implanttrial and a second cutting tip that extends beyond the fourth surface ofthe implant trial.
 50. The method of claim 49, wherein step b) furthercomprises orienting the implant trial in the sacroiliac joint space suchthat: the third side of the implant trial faces the sacrum and thefourth side of the implant trial faces the ilium; and, during step c)the cutting element is distally translated to make the cut extendinginto the sacrum and ilium such that the first cutting tip of each of thefirst member and second member of the cutting element cuts into thesacrum and the second cutting tip of each of the first member and secondmember cuts into the ilium.
 51. The method of claim 50, wherein step a)further comprises approaching a posterior aspect of the sacroiliac jointspace with the joint preparation tool and step b) further comprisesdelivering the joint preparation tool through an access region definedbetween a posterior superior iliac spine and a posterior inferior iliacspine.
 52. The method of claim 51, further comprising: d) delivering animplant into the sacroiliac joint space.
 53. The method of claim 52,wherein at least a portion of the implant occupies a space resultingfrom the cut extending into at least one of the sacrum or the ilium. 54.The method of claim 53, wherein the at least a portion comprises a keelof the implant.
 55. The method of claim 53, wherein the implantcomprises: an intraarticular element extending an implant length betweenan implant proximal end and an implant distal end, and further extendingan implant height between an implant upper edge and an opposed implantlower edge, the intraarticular element comprising a first articular faceand a second articular face opposite the first articular face, the firstand second articular faces extending the implant height and at least aportion of the implant length; a graft window formed within at least aportion of the intraarticular element and extending through theintraarticular element from the first articular face to the secondarticular face; and at least one keel attached to the intraarticularelement along at least a portion of the implant length.
 56. The methodof claim 55, wherein the at least one keel comprises a first keelextending from the implant proximal end to the implant distal end,wherein the first keel is attached along the implant upper edge or theimplant lower edge.
 57. The method of claim
 56. wherein the at least onekeel further comprises a second keel extending from the implant proximalend to the implant distal end, wherein the second keel is attached alongthe implant upper edge or the implant lower edge opposite to the firstkeel.
 58. The method of claim 57, wherein at least one of theintraarticular element and the at least one keel distally tapers into adistal edge of the implant.
 59. The method of claim 52, wherein theimplant approximates a shape and size of the implant trial.
 60. Themethod of claim 51, wherein each of the first and second cutting tips ofeach of the first and second members comprises a serrated face having aseries of cutting teeth, wherein the serrated face tapers from aproximal end to a distal end of each cutting tip.
 61. The method ofclaim 31, wherein the implant trial further comprises a channel formedin a surface that extends at least a portion of the length of theimplant trial, the channel guiding the cutting element in an arcuatepath during step c).
 62. The method of claim 31, wherein the implanttrial portion comprises a first cylindrical shaft, and the cutting toolportion comprises a second cylindrical shaft.
 63. The method of claim31, wherein the implant trial further is configured to be reversiblysecured within the sacroiliac joint space by a locking element.
 64. Themethod of claim 63, further comprising fixing the implant trial relativeto the sacroiliac joint space via the locking element.
 65. The method ofclaim 63, wherein the implant trial includes at least one passagewaywhich communicates between an inner portion of the implant trial and anouter surface of the implant trial, and wherein the method furthercomprises securing the implant trial within the sacroiliac joint spacevia causing an anchoring member to reversibly transition from a recessedcondition to a deployed condition, the recessed condition being when theanchoring member is recessed within the passageway and not engaging abone defining the sacroiliac joint, the deployed condition being when atleast a portion of the anchoring member projects out of the passagewayfrom the outer surface of the implant trial and engaging at least onebone defining the sacroiliac joint, the anchoring member configured tolimit the movement of the implant trial during step c).
 66. The methodof claim 63, wherein a proximal surface of the implant trial includes atleast one passageway which communicates with a portion of an outersurface of the implant trial, the portion being distal to the proximalsurface, the passageway configured to receive an anchoring membercomprising the locking element.
 67. The method of claim 66, furthercomprising securing the implant trial within the sacroiliac joint spacevia the anchoring member by acting upon a proximal end of the anchoringmember to reversibly transition the anchoring member from a recessedcondition to a deployed condition, the recessed condition being when theanchoring member is recessed within the passageway and not engaging abone defining the sacroiliac joint, the deployed condition being when adistal end of the anchoring member projects out of the passageway fromthe portion of the outer surface of the implant trial and engaging atleast one bone defining the sacroiliac joint, the anchoring memberconfigured to limit the movement of the implant trial during step c).68. The method of claim 67, wherein the anchoring member comprises atleast one of a spike, pin, dart or screw.
 69. The method of claim 31,further comprising: d) delivering an implant into the sacroiliac jointspace.
 70. The method of claim 69, wherein at least a portion of theimplant occupies a space resulting from the cut extending into at leastone of the sacrum, the ilium or the sacroiliac joint space.
 71. Themethod of claim 70, wherein the at least a portion comprises a keel ofthe implant.
 72. The method of claim 69, wherein the implantapproximates a shape and size of the implant trial.
 73. The method ofclaim 23, wherein the implant trial further comprises a first sidesurface, a second side surface, and a guide wire bore, the first sidesurface extending between the first top surface and the first bottomsurface on a first side of the implant trial, the second side surfaceextending between the first top surface and the first bottom surface ona second side of the implant trial that is opposite the first side, theguide wire bore extending through the implant trial from the distal tothe proximal end and configured to receive and be guided into thesacroiliac joint space by a guide wire.
 74. The method of claim 73,wherein the implant trial further comprises a channel formed in thefirst top surface that extends at least a portion of the first length ofthe implant trial, the channel comprising a head region and a contractedneck region, wherein the cutting element further comprises a cuttingelement guide extending at least a portion of the second length, thecutting element guide configured to fit within the head region and thecontracted neck region.
 75. The method of claim 74, wherein the cuttingelement guide is configured to be received within the head region andthe contracted neck region when the cutting element distally convergeswith the implant trial such that, once converged, the cutting element isrestrained from rotating relative to the implant trial via the cuttingelement guide fitting within the head region and the contracted neckregion.
 76. The method of claim 75, wherein the head region includes acylindrical portion.
 77. The method of claim 31, wherein prior to stepb), the method further comprises creating a void generally parallel to aplane of the sacroiliac joint, the void generally sized and shapedsufficiently to receive the implant trail during step b).
 78. The methodof claim 77, wherein creating the void comprises approaching thesacroiliac joint space with: an access cannula having a length and afirst jig configured to fit within the access cannula, the first jigconfigured to guide a second cutting tool therethrough and into thesacroiliac joint space.
 79. The method of claim 78, further comprisingorienting the access cannula such that the length is generally parallelto a plane of the sacroiliac joint, delivering the second cutting toolthrough the first jig along the access cannula length and into thesacroiliac joint space.
 80. The method of claim 79, further comprisingdelivering a box osteotome into the sacroiliac joint space.
 81. Themethod of claim 79, further comprising delivering a rasp into thesacroiliac joint space.
 82. The method of claim 79, further comprising:d) delivering an implant along the access cannula length and into thesacroiliac joint space.
 83. The method of claim 82, wherein the accesscannula comprises an exterior surface having a substantiallynon-circular cross-section perpendicular to the length.
 84. The methodof claim 83, wherein the exterior surface comprises a pair of planarwalls opposite and generally parallel to one another and extending thelength, and a pair of curved walls opposite one another and extendingthe length, wherein each curved wall is positioned between and connectedto the pair of planar walls.
 85. The method of claim 84, wherein a widthseparating the pair of planar walls is substantially less than theheight separating the pair of curved walls.
 86. The method of claim 83,wherein the exterior surface comprises a lateral wall opposite a medialwall, each lateral and medial wall extending the length, and a superiorwall opposite an inferior wall, each superior and inferior wallextending the length, wherein the lateral and medial walls are separatedby a width which is substantially less than a height separating thesuperior and inferior walls.
 87. The method of claim 86, furthercomprising orienting the access cannula such that the lateral wall facesgenerally laterally, the medial wall faces generally medially, theinferior wall faces generally caudally and the superior wall facesgenerally cranially.
 88. The method of claim 87, wherein a distal end ofthe inferior wall is positioned generally adjacent a posterior inferioriliac spine.
 89. The method of claim 87, wherein step a) furthercomprises approaching a posterior aspect of the sacroiliac joint spacewith the joint preparation tool and step b) further comprises deliveringthe joint preparation tool through an access region defined between aposterior superior iliac spine and a posterior inferior iliac spine. 90.The method of claim 89, wherein prior to step b), the method furthercomprises approaching a posterior aspect of the sacroiliac joint spacewith a guide pin and a joint finder, the joint finder comprising alength between a distal and proximal end and a cannulated body extendingbetween the distal and proximal ends, the cannulated body comprising aflattened end portion alignable with a sacroiliac joint plane andcomprising a first planar surface opposite a second planar surface; and,the method further comprising delivering the guide pin into and alongthe sacroiliac joint plane and orienting the flattened end portion firstplanar surface such that it opposes the sacrum and the flattened endportion second planar surface opposes the ilium, and delivering thejoint finder over the guide pin being received by the cannulated bodyand advanced into the sacroiliac joint plane.
 91. The method of claim89, further comprising approaching the sacroiliac joint space with anaccess cannula having a length, an exterior surface having asubstantially non-circular cross-section perpendicular to the length,the exterior surface comprises a lateral wall opposite a medial wall,each lateral and medial wall extending at least a portion of the length,and a superior wall opposite an inferior wall, each superior andinferior wall extending at least a portion of the length, wherein thelateral and medial walls are separated by a width which is substantiallyless than a height separating the superior and inferior wails, andorienting the access cannula such that i) the length is generallyparallel to a plane of the sacroiliac joint, and ii) the lateral wallfaces generally laterally, the medial wall faces generally medially, theinferior wall faces generally caudally and the superior wall facesgenerally cranially.
 92. The method of claim 91, wherein the accesscannula further comprises a distal projection extending distally off adistal opening of the access cannula from at least one of the superioror inferior walls.
 93. The method of claim 91, wherein the at least oneof the lateral or medial walls extends only a portion of the lengthwhile the superior and inferior walls extend the length.
 94. The methodof claim 91, wherein a distal end of the inferior wall is positionedgenerally adjacent a posterior inferior iliac spine.
 95. The method ofclaim 89, further comprising: d) delivering an implant into thesacroiliac joint space.
 96. The method of claim 95, wherein at least aportion of the implant occupies a space resulting from the cut extendinginto at least one of the sacrum or the ilium.
 97. The method of claim96, wherein the at least a portion comprises a keel of the implant. 98.The method of claim 95, wherein the implant approximates a shape andsize of the implant trial.
 99. The method of claim 31, wherein the jointpreparation tool further comprises an anchor arm assembly, the methodfurther comprising employing the anchor arm assembly to deliver ananchoring element into the sacrum and the ilium.
 100. The method ofclaim 31, further comprising: delivering an implant into the sacroiliacjoint space; approaching the sacroiliac joint with a delivery toolcomprising an implant arm configured to support the joint implant and ananchor arm assembly comprising an arcuate portion slidable relative tothe implant arm and having an anchor guide portion; and delivering ananchor into at least one of the sacrum or ilium via the anchor guideportion.
 101. The method of claim 31, wherein the method furthercomprises selecting the implant trial from a kit comprising varioussizes of implant trials, the implant trial selected based on an implanttrail which best fits the joint space.
 102. The method of claim 31,wherein the method further comprises selecting the cutting tool from akit comprising a plurality of cutting tools, the plurality of cuttingtools comprising different sized cutting elements; and, repeating stepc) more than once using multiple of the plurality of cutting tools. 103.The method of claim 31, wherein the joint preparation tool furthercomprises an indicator configured to permit a navigation system toprovide data related to the position and orientation of the jointpreparation tool.
 104. The method of claim 103, wherein the navigationsystem comprises at least one of optical or electromagnetic trackingoptions.
 105. The method of claim 104, wherein the indicator comprises areference array.
 106. The method of claim 105, wherein the indicatorcomprises a frame coupled to the joint preparation tool.
 107. The methodof claim 106, Wherein the indicator comprises at least three trackingelements supported and connected to one another by the frame in apredetermined spaced apart arrangement.